MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-11-20 for 2.0MM MLP BENDER/CUTTER 329.143 manufactured by Synthes Tuttlingen.
[5297742]
It was reported that a mandibular fracture surgery was performed on (b)(6) 2014. Intra-operatively, the surgeon attempted to use a 2. 0mm mandible locking plate bender/cutter to bend a 2. 4mm titanium limited contact dynamic compression plate at the back table when the tip of the bender/cutter broke. The tip was retrieved. The surgeon used a bigger size bender/cutter and was able to bend the same plate. The plate was used in the patient. The surgery was successfully completed without patient harm or surgical delay. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12538904]
Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[34412701]
A device history review was conducted. The report indicates that the device history record review could not be performed as the records could not be identified. The device is over 9 years old. (b)(4). 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
| Report Number | 2520274-2014-14831 |
| MDR Report Key | 4266438 |
| Report Source | 05,07 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-10-28 |
| Date of Event | 2014-10-28 |
| Date Mfgr Received | 2014-11-17 |
| Device Manufacturer Date | 2005-05-25 |
| Date Added to Maude | 2014-11-20 |
| 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 | 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 | 2.0MM MLP BENDER/CUTTER |
| Generic Name | INSTRUMENT,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-11-20 |
| Returned To Mfg | 2014-11-17 |
| Catalog Number | 329.143 |
| Lot Number | A7 OA 21 |
| 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 PA 19380785 GM 19380 7853 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-20 |