MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-01-07 for ATTUNE FB CR ARTIC SURF SZ7 254500527 manufactured by Depuy Orthopaedics, Inc..
[35276753]
(b)(4). This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. 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
[35276754]
The pegs broke off the attune trials.
Patient Sequence No: 1, Text Type: D, B5
[36376189]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. 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
[37293707]
Examination of the returned devices confirms the reported event of trial breakage. Hhe/qrb (quality review board) 103045639 recommended a device correction which was initiated on (b)(6) 2015. (b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants. (b)(4) will also monitor the mandatory field training. The need for further corrective action was not indicated. Continue to monitor per post market surveillance (b)(4). Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2016-10273 |
| MDR Report Key | 5351297 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-01-07 |
| Date of Report | 2016-01-05 |
| Date of Event | 2016-01-05 |
| Date Mfgr Received | 2016-01-13 |
| Device Manufacturer Date | 2013-06-20 |
| Date Added to Maude | 2016-01-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE FB CR ARTIC SURF SZ7 |
| Generic Name | KNEE INSTRUMENT/TRIAL |
| Product Code | KWH |
| Date Received | 2016-01-07 |
| Returned To Mfg | 2016-01-11 |
| Catalog Number | 254500527 |
| Lot Number | MVMBKY460 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-07 |