MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-07 for SYMMETRY SURGICAL NEEDLE DRIVER manufactured by Symmetry Medical Manufacturing Inc..
[161602168]
Black residue identified on jaws of needle holders with tungsten carbide inserts. Residue found after instruments had been through the sterilization process but prior to start of surgical procedure. Black residue tested and found to be negative for bioburden. Micro performed on the substance is negative. This was able to be replicate with multiple needle holders of various sizes by wiping with cloth soaked in saline. Composition of black residue unk at this time. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5090247 |
| MDR Report Key | 9166216 |
| Date Received | 2019-10-07 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-10-01 |
| Date Added to Maude | 2019-10-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY SURGICAL NEEDLE DRIVER |
| Generic Name | HOLDER, NEEDLE, ORTHOPEDIC |
| Product Code | HXK |
| Date Received | 2019-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY MEDICAL MANUFACTURING INC. |
| Manufacturer Address | WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-07 |