MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-03 for KNIFE LIGHT 10/PK 3300-001-000 manufactured by Stryker Osteosynthesis-freiburg.
[3529228]
It was reported that during carpal tunnel procedure while using the knifelight, (b)(4) a piece broke off.
Patient Sequence No: 1, Text Type: D, B5
[10792421]
Investigation in progress but not yet complete.
Patient Sequence No: 1, Text Type: N, H10
[15013446]
It was reported that during carpal tunnel procedure while using the knifelight, ref # (b)(4) a piece broke off.
Patient Sequence No: 1, Text Type: D, B5
[15332977]
The reported event could not be confirmed because there were deformation and cracks in the transparent surrounding instead of breakage. The visual investigation showed that the deformation and cracks of the transparent surrounding was caused by too strong forces in terms of a bending overload during use of the device. Furthermore, it was possible to turn on the light. Based on the performed investigation, no indications were found for any systematic, design or manufacturing related issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0008010177-2013-00107 |
| MDR Report Key | 3141037 |
| Report Source | 07 |
| Date Received | 2013-06-03 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-05-02 |
| Date Mfgr Received | 2013-05-09 |
| Date Added to Maude | 2013-08-20 |
| 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 | MR. MANISH PATEL |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS-FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KNIFE LIGHT 10/PK |
| Generic Name | SURGICAL INSTRUMENT |
| Product Code | FSQ |
| Date Received | 2013-06-03 |
| Returned To Mfg | 2013-05-27 |
| Catalog Number | 3300-001-000 |
| Lot Number | 12138FE2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS-FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-03 |