MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION FORCEPS; INSTRUMENT COMPRESSION

Model Number	03.211.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, it was discovered that a compression forceps was broken.There was no patient involvement.This complaint involve one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device evaluated by mfr, device manufacture date: part 03.211.400, lot: t961302: release to warehouse date: july 27, 2011.Manufacture site: tuttlingen.A review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used raw material was according to the specification of the device.No non-conformance reports (ncrs) were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Device evaluated by mfr: a product investigation was completed: visual inspection of the returned device confirmed the condition of device breakage, which agrees with the reported complaint condition.The leaf spring component has broken at the location where it is secured to the handle with a screw.Both sections of the leaf spring remain secured to the handle with the screw but it is clear that the leaf spring has broken completely in half.The relevant design drawings were reviewed during this investigation.The 03.211.400 compression forceps are a reusable instrument routinely used in the 2.4mm/2.7mm variable angle lcp forefoot / midfoot system.No product design issues or discrepancies were observed during this investigation.The thickness of the broken leaf spring at location of breakage measured within specification.The width of the broken leaf spring at location of breakage measured within.The design specified the leaf spring to be manufactured from 1.4021 stainless steel and hardened.The raw material certificate was reviewed and the used raw material was according to the specification of the device.A definitive root cause for the leaf spring breaking could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: COMPRESSION FORCEPS
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8090701
• Report Number: 2939274-2018-55047
• Device Sequence Number: 1747618
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2018

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 Model Number: 03.211.400
• Device Catalogue Number: 03.211.400
• Device Lot Number: T961302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 11/03/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1