MAUDE Adverse Event Report: SYNTHES TUTTLINGEN COMPRESSION FORCEPS; INSTRUMENT COMPRESSION

Catalog Number	03.211.400
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device is an instrument and is not implanted/explanted.Manufacturing date: april 29, 2011.Review of the device history record (dhr) of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All parts of the lot were checked 100% for important features and for function at the final inspection.No non-conformance reports were generated during production.A product investigation was completed: the returned compression forceps were found to have wear to the teeth of the ratcheting rail.The flap was found to be broken with a fragment missing where it contacts the ratcheting rail.The device does not translate smoothly; however, the device is able to lock and hold in place.No other issues were noted with the device.The damage to the device has the potential to lead to the reported complaint condition, but the issue was not able to be replicated.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.The relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The issue was likely caused by excessive force on the device during use.There were no issues during the manufacture of this product that would contribute to this complaint condition.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.
Event or Problem Description
It was reported that during a first mtp (metatarsophalangeal) joint fusion the compression forceps malfunctioned.While using the device it did not hold in the compression mode, the switch was not working as intended.The physician assistant had to manually hold the forceps in place.There was a minimal delay of approximately five (5) minutes.There was no patient harm and patient is reported as being stable.While the returned device was being investigated, it was noted that the returned compression forceps were found to have wear to the teeth of the ratcheting rail.The flap was found to be broken with a fragment missing where it contacts the ratcheting rail.This is report 1 of 1 for (b)(4).

• Brand Name: COMPRESSION FORCEPS
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6367599
• Report Number: 9680938-2017-10029
• Device Sequence Number: 442931
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267(10)T961236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.211.400
• Device Lot Number: T961236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 86