MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-08 for BEND/CUT-PLIERS W/NOSE F/LOCK-PL 2 329.143 manufactured by Synthes Gmbh.
[3887123]
Device report from synthes (b)(6) reports an event in (b)(6) as follows: the nose of the plate was broken. This product was broken in the operation on (b)(6) 2013. When the surgeon tried to bend the plate by the nose with bending/cutting pliers, the nose broke. After the operation, the sales rep visited the hospital for the follow-up and became aware of the issue on (b)(6) 2013. The surgeon thought it may have been caused due to metal fatigue since it occurred during the bending. There was no effect on the patient. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10943373]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. A review of the device history records was performed and no complaint related issues were found. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[26018776]
An investigation was conducted and it states the nose was broken away on the smallest cross-section of material. The present pliers was analyzed for conformance to print specifications as well as the device history record was researched. The thickness of the article was measured and found to be out of specifications on one section. An internal investigation was conducted. The breakage of the nose occurred due to the pointed out cross-section. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[26018777]
(b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2013-04549 |
| MDR Report Key | 3270793 |
| Report Source | 01,07 |
| Date Received | 2013-08-08 |
| Date of Report | 2013-07-16 |
| Date of Event | 2013-07-06 |
| Date Mfgr Received | 2013-09-09 |
| Device Manufacturer Date | 2011-12-08 |
| Date Added to Maude | 2013-11-04 |
| 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 | W. LINDENMUTH |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEND/CUT-PLIERS W/NOSE F/LOCK-PL 2 |
| Product Code | HXP |
| Date Received | 2013-08-08 |
| Returned To Mfg | 2013-07-29 |
| Catalog Number | 329.143 |
| Lot Number | 7695620 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-08 |