MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for BENDING PLIERS-SMOOTH JAWS FORMINI PLATES 329.12 manufactured by Synthes Salzburg.
[71738023]
Device was used for treatment, not diagnosis. There was no reported patient involvement associated with the complained event. Date of event: unknown. Device is an instrument and is not implanted/explanted. The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history record review was performed for the subject device lot. Manufacturer: synthes (b)(4). Date of manufacture: apr 14, 2008. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[71738024]
It was reported on (b)(6) 2017 that the hospital? S technician from central serial processing department had two (2) broken instruments that came down from the operating room. The bending pliers were broken into two pieces at the instrument hinge and the depth gauge is reported as broken at the distal tip. No additional information was given from the hospital, and nothing else is forthcoming. There was no reported patient involvement associated with the reported event; however, it is unknown when the reported device were broken. The reported issues were discovered during instrument inspection. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[73823281]
Device was used for treatment, not diagnosis. The subject device has been received by the manufacturer and is undergoing investigation. The results of the investigation are pending completion and will be submitted in a supplemental report. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[74805252]
A product development investigation was performed for the subject devices. This complaint is confirmed for the returned 329. 12 pliers. The returned pliers are broken as reported. A portion of the hinge pin/screw has sheared off and is missing from the device and therefore the device is now in two pieces. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned pliers are already broken. This complaint is not confirmed for the returned 319. 04 depth gauge. The tip of the measuring hook on the returned depth gauge is bent, but not broken as reported. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already bent. No new malfunctions were identified as a result of the investigation. A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, and drawing review were performed as part of this investigation. Part# 329. 12 bending pliers-smooth jaws for mini plates: the returned pliers are broken as reported. A portion of the hinge pin/screw has sheared off and is missing from the device and therefore the device is now in two pieces. The diameter of the hinge pin/screw that sheared in half could not be measured at cq as one portion is missing and one portion is inaccessible (still retained in one half of the pliers). Drawing was reviewed during this investigation. No product design issues or discrepancies were observed. The root cause is most likely due to application of excessive force which exceeded the shear strength of the hinge pin/screw. Part# 319. 04 depth gauge for 2. 7mm & small screws: the tip of the measuring hook on the returned depth gauge is bent, but not broken as reported. The height of the distal hook measured 1. 79mm (calipers) at cq which is within specification of 1. 70mm-1. 80mm per measuring hook component drawing. Depth gauge assembly drawing and hook component drawing were reviewed during this investigation. No product design issues or discrepancies were observed. The bent condition of the measuring hook tip most likely is due to rough handling. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009417901-2017-10009 |
| MDR Report Key | 6453625 |
| Date Received | 2017-04-03 |
| Date of Report | 2017-03-10 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2008-04-14 |
| Date Added to Maude | 2017-04-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SALZBURG |
| Manufacturer Street | KAROLINGERSTRASSE |
| Manufacturer City | SALZBURG 5020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 5020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING PLIERS-SMOOTH JAWS FORMINI PLATES |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2017-04-03 |
| Returned To Mfg | 2017-04-04 |
| Catalog Number | 329.12 |
| Lot Number | 5018220 |
| 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 SALZBURG |
| Manufacturer Address | KAROLINGERSTRASSE SALZBURG 5020 AU 5020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-03 |