FDA Adverse Event
Malfunction
Summary report: N
QUICKSET 1PC FLEX DRILL BIT 25
MDR report key: 13507201
·
Received February 10, 2022
Report
- Report Number
- 1818910-2022-02690
- Event Type
- Malfunction
- Date Received
- February 10, 2022
- Date of Event
- January 4, 2022
- Report Date
- February 10, 2022
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- HTW
- UDI-DI
- 10603295109129
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: A BLIND DEVICE WITH NO INFORMATION OR ANY ALLEGATION WAS RECEIVED. EXAMINATION OF THE RETURNED DEVICE FOUND A BENT CONDITION AT THE TIP. ADDITIONALLY, SOME MARKS AND SCRATCHES WERE NOTED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. COMPONENT CODE: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT: PRODUCT RECEIVED AT PAL JRZ: - PRODUCT CODE: 227425500. - LOT NUMBER: PG308486.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670284 | QUICKSET 1PC FLEX DRILL BIT 25 | DRILLS (BITS, SLEEVES, GUIDES) : DRILLS | HTW | DEPUY ORTHOPAEDICS INC US | 2274-25-500 | PG308486 | 10603295109129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |