MAUDE Adverse Event Report: SYNTHES TUTTLINGEN SCREW AND PLATE HOLDING FORCEPS

Catalog Number	347.985
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient involvement.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.A review of the device history records has been completed.Manufacturing site: (b)(4).Manufacturing date: december 13, 2007 review of the device history record 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 (b)(4) parts of the lot were checked 100% and for function at the final inspection on 10-dec-2007 and found conforming.No non-conformance records (ncrs) were generated during production.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 is reported while restocking a mini-fragment set, it was noted one of the tips on the screw and plate holding forceps is broken off.No patient or surgical involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a product investigation was completed: a device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Per the technique guide, the screw and plate holding forceps (347.985) are noted as an additional or optional instrument in both the 1.5mm headless compression screw and the 2.4mm cannulated screw systems.The forceps are specifically utilized for screw and plate handling/placement intra-operatively.The complaint condition is confirmed as the device was received with the left tip broken and the right tip intact but bent laterally.The break on the left tip and origin of the bend on the right tip are each approximately 2mm from the distal tip.The broken portion was not received.The balance of the device shows surface wear consistent with use and is in functional condition.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.Based on the date of manufactured the relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No definitive root cause was able to be determined as the circumstances leading to the failure are unknown.However, the condition is consistent with the distal tips being exposed to exceeding forces which would not be expected from typically use.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: SCREW AND PLATE HOLDING FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6260304
• Report Number: 9680938-2017-10004
• Device Sequence Number: 10900426
• Product Code: HTD
• UDI-Device Identifier: 10886982193629
• UDI-Public: (01)10886982193629(10)A7QA50
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2016

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 347.985
• Device Lot Number: A7QA50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1