MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE; SCREWDRIVERS

Model Number	313.97
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.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an unknown date, during incoming inspection of a loaner set, it was observed that the 2.4mm cruciform screwdriver with holding sleeve was damaged with a broken handle.There was no patient involvement.This complaint involves 1 device.This report is for (1) holding sleeve.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d10.G1.H3, h4, h6: lot 3192913 is associated to article 313.940 which belongs to article 313.970.Hence, dhr review will be performed with 313.940 and lot 3192913: part: 313.940.Lot: 3192913.Manufacturing site: hägendorf.Release to warehouse date: 19.Jun.2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the holding sleeve (product code: 313.97 & lot no: 3192913) was received at us customer quality (cq) with all components disassembled.Upon visual inspection and assembly of all components, no breakage or defect was observed on the device.No other issues were identified on the device.Device failure/defect identified? no failure detected.Investigation conclusion: the complaint was not confirmed for the received holding sleeve as no defect or failure identified on the device.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 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: HOLDING SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10182588
• Report Number: 2939274-2020-02927
• Device Sequence Number: 835403
• Product Code: HXX
• UDI-Device Identifier: 10887587037196
• UDI-Public: (01)10887587037196
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 313.97
• Device Catalogue Number: 313.97
• Device Lot Number: 3192913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1