MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for ATTUNE PS & CR TRLS SZ 9-10 2545-01-710 254501710 manufactured by Depuy Ireland - 9616671.
[188204455]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188204456]
It was reported that recently the operating room staff has been finding black specs in the sets. They are very small black specs. They asked the operating room to send me samples of these black specs. They were mostly found on the bottom of the trays inside the wrappers. A few times they found specs inside the corner protectors that they used. The inside wrap was white so they are easy to identify. What they found was that the black bumpers on the trays which provides protection was peeling off. Perhaps during the transportation and stacking of trays the bumper material breaks down. Not sure if you have received any other concerns about this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08272 |
| MDR Report Key | 9842799 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE PS & CR TRLS SZ 9-10 |
| Generic Name | ATTUNE INSTRUMENTS : INSTRUMENT CASES |
| Product Code | FSM |
| Date Received | 2020-03-17 |
| Model Number | 2545-01-710 |
| Catalog Number | 254501710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |