MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING; TAP,BONE

Catalog Number	311.01.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 field inspection at the sterile processing department on (b)(6) 2019, the handle of the mini quick coupling handle was discovered broken.There were no patient and surgical involvement.This complaint involves one (1) device.This report is for one (1) handle with mini quick coupling.This is report 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.H10 additional narrative: d4 suspected lot a4q7372.H3, h4, h6 investigation summary.Visual inspection: the handle with mini quick coupling (p/n: 311.01.96, lot #: a4q7372) was returned and received at us cq.Upon visual inspection, it was observed that the handle of the device was broken into multiple pieces and broken pieces were received at cq.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Service & repair evaluation: the customer reported the device had an unknown malfunction.The repair technician reported the handle was broken into multiple pieces.Handle cracked/broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed handle w/mini quick coupling: handle: complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion : the complaint condition is confirmed for the handle with mini quick coupling (p/n: 311.01.96, lot #: a4q7372).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: the reported part and lot # were not available in jde.Lot number etched on the device is not clear due to the damage.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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: HANDLE WITH MINI QUICK COUPLING
• Common Device Name: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9185958
• Report Number: 2939274-2019-61479
• Device Sequence Number: 2538114
• Product Code: HWX
• UDI-Device Identifier: 10886982187208
• UDI-Public: (01)10886982187208
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Catalogue Number: 311.01.96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1