MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for UNKNOWN CONFIDENCE NEEDLE UNK ? SPINAL INSTRUMENT manufactured by Depuy Synthes Spine.
[69339642]
A follow up report will be filed upon completion of the investigation. 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
[69339643]
Confidence needle broken intraoperative in situ with a length of 4 cm. Needle fragment had to be removed with tap and parent bore part be removed, complete removal impossible. As a result no harm of the patients because remaining of needle fragment in the bone according to surgeon.
Patient Sequence No: 1, Text Type: D, B5
[73286683]
The unknown confidence needle was not returned to the customer quality unit (cqu) for evaluation. The sample status has been changed to? None.? Should more information and/or the device sample become available at a later date, this complaint file will be reopened and the device will then receive a full evaluation. A review of the device history record (dhr) for the unknown confidence needle could not be conducted as no lot number was provided. Also, the sample device was not returned to the cqu from which the lot number could be taken directly from the sample. Therefore, without the lot number, no review of the manufacturing records could be completed. No emerging trends were found requiring further actions. Without the return of the unknown confidence needle we are unable to confirm the reported issue or identify the root cause. 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
| Report Number | 1526439-2017-10164 |
| MDR Report Key | 6377266 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-03-15 |
| Date Added to Maude | 2017-03-03 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CONFIDENCE NEEDLE |
| Generic Name | UNKNOWN |
| Product Code | OAR |
| Date Received | 2017-03-03 |
| Catalog Number | UNK ? SPINAL INSTRUMENT |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |