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

Model Number	391.882
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part returned.A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2019, after a case done over the weekend, the surgeon was doing a hemiarthroplasty.The surgeon needed a cable to secure potential pending fracture, but when the surgeon went to crimp the cable, the cable crimper was not working it would not hold the crimper in place.So another set was opened and another crimper was used.No delayed to the case.Concomitant device reported: unk - cable/wire accessories: trauma (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.The cable crimper (part # 391.882, lot # p312513, mfg # 31-may-2006) was received at us cq with some signs of wear on the device but overall the device was in good working condition.A functional test was performed, and the ratchet handle worked as it should.The crimper was able to crimp.The complaint was not able to be replicated and not consistent with the reported condition, therefore the complaint is not confirmed.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part number: 391.882 synthes lot number: p312513 supplier lot number: p312513 release to warehouse date: 31-may-2006 manufacturing site: synthes monument supplier: pioneer surgical no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.

• 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: 8586757
• Report Number: 2939274-2019-57864
• Device Sequence Number: 19291806
• Product Code: LXH
• UDI-Device Identifier: 10886982198341
• UDI-Public: (01)10886982198341
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: P312513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE ACCESSORIES; UNK - CABLE/WIRE ACCESSORIES