MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-09 for BENDING IRON FOR 2.7MM & 3.5MMRECONSTRUCTION PLATES 329.07 manufactured by Synthes Tuttlingen.
[5340393]
It was reported that a small piece of a plate bender broke off during a surgical procedure. On (b)(6)2015, the patient underwent repair of a fractured right clavicle. As the surgeon attempted to bend a 2. 7 millimeter locking compression plate (lcp) with a plate bender from an lcp small fragment set, the small cylinder within the curved end of the bender broke off which made the plate fall on the floor. Surgery was delayed for 30 minutes in order to locate a different plate bender from another set. The broken device was removed easily, without additional intervention. It was reported that the surgery was successfully completed. This report is 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13023969]
Device was used for treatment, not diagnosis. Device instrument and is an is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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
[19520108]
Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Manufacturing date: november 17th, 2003 the device history record review could not be performed as the records could not be identified due to the age of the instrument. This dhr is approx. 11 1/2 years old. Device was used for treatment, not diagnosis. 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
[21816980]
Device was used for treatment, not diagnosis. Additional narrative: patient age was reported as (b)(6). Product development investigation was performed for the subject device. One bending iron, for 2. 7mm and 3. 5mm reconstruction plates (part number 329. 07, lot number a7ma46) was received with the complaint category of? Broken: intraoperatively.? Further evaluation shows that the returned device is intended for use to contour 2. 7mm & 3. 5mm small fragment reconstruction locking compression plates and proper use and maintenance is addressed in the small fragment locking compression plate (lcp) system technique guide and the 3. 5mm lcp hook plate technique guide. The returned bending iron was received with the smaller pin, used to position and contour plates, broken off. This pin, approximately 4. 5mm long, was not returned. The fracture surface is located flush with the body of the device and is uniform. There are no indications of any material anomalies. The balance of the device shows wear but is otherwise in good condition. Thus, the complaint condition is confirmed but cannot be replicated since the device is already broken. Based on the pin design the device drawings were identified. A review of the current design drawing and manufactured design was performed. No drawing issues or discrepancies were noted and the design was found to be sufficient for its intended use. The design history was found to not impact the complaint condition. Therefore, the complaint condition was determined to not be the result of a design deficiency. The received condition is consistent with fatigue failure from repeatedly being subjected to high bending forces. This particular instrument is approximately 11. 5 years old. Thus, this complaint condition is most likely the result of accumulated wear over the life of the instrument and/or the method of use. The complaint condition was determined to not be the result of a design deficiency. 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 | 9680938-2015-10027 |
| MDR Report Key | 4580574 |
| Report Source | 05,07 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-02-24 |
| Date of Event | 2015-02-24 |
| Date Mfgr Received | 2015-04-09 |
| Device Manufacturer Date | 2003-11-17 |
| Date Added to Maude | 2015-03-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING IRON FOR 2.7MM & 3.5MMRECONSTRUCTION PLATES |
| Generic Name | INSTR, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-03-09 |
| Returned To Mfg | 2015-03-03 |
| Catalog Number | 329.07 |
| Lot Number | A7MA46 |
| 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 TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |