FDA Adverse Event
Malfunction
Summary report: N
HEALICOIL REGENESORB
MDR report key: 3935503
·
Received July 15, 2014
Report
- Report Number
- 1219602-2014-00206
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- July 11, 2014
- Report Date
- July 11, 2014
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- MBI
- PMA / PMN Number
- K123393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS. (B)(4).
Description of Event or Problem · 1
DURING A ROTATOR CUFF REPAIR USING THE HEALICOIL RG SA 4.75MM W/2 UB-BL, CBRD BL, IT WAS REPORTED THAT AS THE ANCHOR WAS BEING INSERTED, IT CRACKED AND BROKE INTO MANY PIECES. THE SURGEON COMPLETED THE PROCEDURE WITH A LARGER SIZE (5.5MM) ANCHOR AND PLACED IT INTO THE SAME SITE. THE PIECES WERE REMOVED WITH GRASPER, IRRIGATION AND FLUSHING. THERE WERE NO REPORTS OF PATIENT INJURIES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414276 | HEALICOIL REGENESORB | HEALICOIL RG SA 4.75MM W/2 UB-BL,CBRD BL | MBI | MANSFIELD MANUFACTURING SITE | 72203704 | 50506918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |