MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-27 for CODMAN NEEDLE HOLDER UNK manufactured by Symmetry Surgical Inc..
[4123830]
During a right long finger a1 pully release with focal tenosynovectomy, and damaged flexor digitorum superficialis procedure, the physician noticed a microscopic piece of metal while closing the wound. The physician was not sure which instrument the metal piece came from. The instruments and the metal piece were removed from the sterile field. X-rays were taken to determine if any metal remained in the pt. The x-ray was negative.
Patient Sequence No: 1, Text Type: D, B5
[11403852]
(b)(6) did not report the part number or lot number of the instruments. They did not return the instrument for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2013-00014 |
| MDR Report Key | 3544735 |
| Report Source | 07 |
| Date Received | 2013-11-27 |
| Date Mfgr Received | 2013-08-23 |
| Date Added to Maude | 2014-03-12 |
| 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 | CHRIS SMITH, DIRECTOR |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN NEEDLE HOLDER |
| Generic Name | NEEDLE HOLDER |
| Product Code | GZX |
| Date Received | 2013-11-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-27 |