MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for HOOK POSITIONER 388.63 manufactured by Synthes Brandywine.
[81124893]
(b)(6). Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Dhr review for part #388. 63, synthes lot #4547325. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. Release to warehouse date: 26-feb-2003. Manufactured by synthes (b)(4). Device was used for treatment, not diagnosis. 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
[81124894]
It was reported that three devices malfunctioned during a t4-l2 scoliosis procedure on (b)(6) 2017. During the procedure, a hook positioner had a chunk come out of the phenolic handle during malleting. The chunk was recovered easily. Later, a socket wrench with straight handle split into two pieces during malleting. All pieces were recovered. Finally, upon final tightening, the surgeon noticed that a titanium (ti) collar with grooves at t8 left was broken toward the end of the procedure. The broken device was easily and quickly removed and another collar was implanted. The procedure was completed with no patient harm. Concomitant devices reported: titanium nut 11mm width across flats (part 498. 003, lot number unknown, quantity 1); 5. 0mm titanium side-opening screw 35mm (part 498. 535, lot number unknown, quantity 1); mallet (part number unknown, lot number unknown, quantity 1). This report is for one (1) hook positioner. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530088-2017-10230 |
| MDR Report Key | 6736677 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2003-02-26 |
| Date Added to Maude | 2017-07-24 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOOK POSITIONER |
| Generic Name | HOOK, SURGICAL, GEN & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2017-07-24 |
| Returned To Mfg | 2017-07-06 |
| Model Number | 388.63 |
| Catalog Number | 388.63 |
| Lot Number | 4547325 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-24 |