MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-11-19 for MODULAR HANDLE, T RATCHETING TORQUE LIMITING 3356-1 manufactured by Zimmer Spine.
[1392071]
On (b) (6) 2009, the sales rep reported that during surgery, the surgeon was using the 3356-1 t-handle and it didn't function properly and the screw 3306-6540 and the closure top 3301-1 stripped. Additional info received via telephone on 28 oct 2009, the sales rep reported that during surgery on l4-l5, the surgeon was loading the closure top on the starter and implanted the closure tops. The surgeon then was ready to final tighten when he was attempting to final tighten the closure top, he never felt the ratcheting handle slip to lock the closure top. The surgeon continued to turn the handle real hard and was not getting it to slip. During this process, the surgeon then stripped the closure top and the screw. The surgeon then explanted the closure top and screw and replaced them with another. The surgeon continued to use the handle, and it would intermittently not work but he was able to finish the case with the handle. There was no surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[8305737]
Product is an instrument and is not implantable. Request has been made for the return of the product. Request has been made to obtain the product. Evaluation is pending upon the return of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649384-2009-00363 |
| MDR Report Key | 1553510 |
| Report Source | 07 |
| Date Received | 2009-11-19 |
| Date of Report | 2009-11-19 |
| Date of Event | 2009-10-20 |
| Date Mfgr Received | 2009-10-21 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2010-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH CLOSNER, RN, BSN, SR SPEC |
| Manufacturer Street | 5301 RIATA PARK COURT, BLDG F |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 5125331981 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODULAR HANDLE, T RATCHETING TORQUE LIMITING |
| Generic Name | SEQUIOA |
| Product Code | GFC |
| Date Received | 2009-11-19 |
| Catalog Number | 3356-1 |
| Lot Number | 47NJ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-19 |