MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for BX/12 STERILE GIGLI SAW 20 656014000 manufactured by Depuy Orthopaedics, Inc..
[60965639]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[60965640]
The sawblade was being used in surgery when the blade broke.
Patient Sequence No: 1, Text Type: D, B5
[64452374]
Conclusion and justification status for mdr: the bx/12 sterile gigli saw 20 associated with the report was not returned for examination. A 2 year search of the complaint database found no other reported events against product code 656014000. The investigation could not identify or verify a root cause about the current reported event without the device to examine. Based on the inability to determine a root cause, the need for corrective action was not indicated. Monitor through (b)(4). Depuy considers the investigation closed at this time. Should 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 | 1818910-2016-31988 |
| MDR Report Key | 6120677 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2017-01-04 |
| Device Manufacturer Date | 2011-10-26 |
| Date Added to Maude | 2016-11-22 |
| 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 | BX/12 STERILE GIGLI SAW 20 |
| Generic Name | GENERAL/MISC INSTRUMENT |
| Product Code | HSO |
| Date Received | 2016-11-22 |
| Catalog Number | 656014000 |
| Lot Number | 159628 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-11-22 |