MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CABLE CRIMPER; MISC ORTHO SURGICAL INSTRUMENT

Model Number	391.882
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned.A review of the device history record.Device history lot: part # 391.882.Synthes lot # p088850.Supplier lot # p088850.Release to warehouse date: 23 mar 2011; 28 mar 2011.Supplier: pioneer surgical technology.No ncr's were generated during production.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation summary: complaint summary: it was reported that on unknown date, the cable crimper mechanisms was not holding anymore, and it looks like the tooth on the crimper was bent or chipped off.It is unknown if there were procedure and patient involvement.This complaint involves one (1) device.Flow: damage.Visual inspection: the cable crimper (part # 391.882, lot # p088850, mfg # 23-mar-2011; 28-mar-2011) was received at us cq with one of the cutter tips deformed and bent.This is consistent with the reported complaint condition, thus confirming the complaint.The product does not look broken however there is displaced material (deformation).Functional test: a functional test was performed and when closed the cable cutter would not tension or tighten.This is consistent with the reported complaint condition, the complaint was able to be replicated, therefore the complaint is confirmed.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed due to post-manufacturing damage.Document/specification review: the following drawing(s) was reviewed; cable crimper orthopaedic cable system: 391_882 rev b.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.
Event or Problem Description
It was reported that on unknown date, the cable crimper mechanisms was not holding anymore and it looks like the tooth on the crimper was bent or chipped off.It is unknown if there were procedure and patient involvement.This complaint involves 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 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.
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 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: CABLE CRIMPER
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8857145
• Report Number: 2939274-2019-59505
• Device Sequence Number: 11238786
• Product Code: LXH
• UDI-Device Identifier: 10886982198341
• UDI-Public: (01)10886982198341
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2019

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: 391.882
• Device Catalogue Number: 391.882
• Device Lot Number: P088850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 01/13/2020
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/03/2019; 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1