BATTERY POWERDRIVER P2
Report
- Report Number
- 0001032347-2021-00455
- Event Type
- Malfunction
- Date Received
- September 28, 2021
- Report Date
- February 10, 2022
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- GEY
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THE POWER DRIVER BATTERY IS A SINGLE-USE ITEM THAT COMES PRE-STERILIZED. THIS BATTERY IS OPENED ON THE BACK TABLE PRIOR TO THE PATIENT ENTERING THE OR AS A PART OF THE INITIAL ROOM SET UP. IF AN ADDITIONAL BATTERY IS NEEDED DURING THE PROCEDURE, THE CIRCULATOR WILL OPEN THE PACKAGE TO THE SCRUB AT THE BACK TABLE. THE PACKAGES ARE INSPECTED PRIOR TO OPENING, AND IF DEBRIS IS IDENTIFIED IN THE PACKAGE, THE PRODUCT IS NOT USED. AS THERE IS NO PATIENT INVOLVEMENT, THERE IS NO CONCERN FOR PATIENT IMPACT (FROM AN OR PERSPECTIVE). PRODUCT IS 100% INSPECTED PRIOR TO RELEASE FROM ZIMMER BIOMET. ALLEGATIONS ARE FOUND IN A DISTRIBUTOR'S INCOMING INSPECTION AND NOT INVOLVED IN A PROCEDURE - INSPECTION CRITERIA MAY DIFFER FROM ZB'S INTERNAL CRITERIA.
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: FLAT TITANIUM PECTUS BAR 11" CAT# JP-0110 LOT# 283130. L-PLT LT REG 2.0 LACTOSORB SYS CAT# 915-2102 LOT# 638640. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 282330. BATTERY POWERDRIVER P2 CAT#50-1010 LOT# 282320. BATTERY POWERDRIVER P2 CAT#50-1010 LOT# 476000. BATTERY POWERDRIVER P2 CAT#50-1010 LOT# 579610. CARROLL-GIRARD SCREW HEX-END CAT# SP-2693 LOT# 818880. LACTO SCR 1.5X4MM 1.5 SYS 2PK CAT# 915-2315 LOT# 727800. LACTOSORB1.5MM XSHAPEEXTPLATE CAT# 915-2423 LOT# 832560. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 692220. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 692220. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 003430. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 003380. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 760440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 657440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 657440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 760510. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 760350. PLATE 4 HOLE WITH GAP 2.0MM CAT# SP-2292 LOT# 480680. STER TRC TF 18.5MM BNT BUR PL CAT# SP-ST-1020B LOT# 147140. STER TRC 2 XD TF 1.5X4.0MM SCR CAT# SP-ST2-6704 LOT# 071120. LACTO SCR 1.5X5MM 1.5 SYS 2PK CAT# 915-2316 LOT# 728470. FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347 - 2021 - 00441, 0001032347 - 2021 - 00442, 0001032347 - 2021 - 00443, 0001032347 - 2021 - 00444, 0001032347 - 2021 - 00445, 0001032347 - 2021 - 00446, 0001032347 - 2021 - 00447, 0001032347 - 2021 - 00448, 0001032347 - 2021 - 00449, 0001032347 - 2021 - 00450, 0001032347 - 2021 - 00451, 0001032347 - 2021 - 00452, 0001032347 - 2021 - 00453, 0001032347 - 2021 - 00454, 0001032347 - 2021 - 00456, 0001032347 - 2021 - 00457, 0001032347 - 2021 - 00458, 0001032347 - 2021 - 00459,, 0001032347 - 2021 - 00460, 0001032347 - 2021 - 00461, 0001032347 - 2021 - 00462, AND 0001032347 - 2021 - 00463.
IT WAS REPORTED THERE WAS FOREIGN MATERIAL FOUND WITHIN STERILE PACKAGING DURING INCOMING INSPECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436734 | BATTERY POWERDRIVER P2 | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | GEY | BIOMET MICROFIXATION | NI | 657440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |