MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8; GUIDE, SURGICAL, INSTRUMENT

Model Number	314.468
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: initial reporter is j&j company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, during a routine incoming inspection of a loaner set at field stocking location (fsl) it was observed that the holding sleeve was missing a piece.There was no known patient or hospital involvement.This complaint involves one (1) device.This complaint is for one (1) holding sleeve for stardrive screwdriver shaft t8 this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation flow: visual.Visual inspection: the holding sleeve for star drive screwdriver shaft t8 (p/n: 314.468, lot #: 7090027) was returned and received at us cq.Upon visual inspection, it was observed, that the device was received disassembled and was missing the coil spring component.No other issues were observed from the returned device.The device failure/defect was identified.Dimensional inspection: there was conclusive evidence, that the returned device was missing a component, so the dimensional inspection was not performed.Service and repair evaluation: the customer reported, the device was missing a piece.The repair technician reported, spring was missing.Missing component 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.Document/specification review: based on the date of manufacture.The current and manufactured revision of drawings were reviewed.The complaint was confirmed.The device received was missing a component.Hence confirming the allegation.Investigation conclusion : the complaint condition was confirmed, for the holding sleeve for star drive screwdriver shaft t8 (p/n: 314.468, lot #: 7090027).There is no indication, that a design or manufacturing issue has caused the complaint condition.And hence the root cause cannot be determined.The potential cause could be, due to device maintenance.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 lot: part number:314.468, synthes lot number: 7090027, supplier lot number: n/a, release to warehouse date: dec 04, 2012, expiration date: n/a, manufactured by synthes jennersville.No ncrs were generated, during production.Device history review: review of the device history record showed, that there were no issues, during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 FOR STARDRIVE SCREWDRIVER SHAFT T8
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11313573
• Report Number: 2939274-2021-00778
• Device Sequence Number: 2737118
• Product Code: FZX
• UDI-Device Identifier: 10886982188939
• UDI-Public: (01)10886982188939
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 314.468
• Device Catalogue Number: 314.468
• Device Lot Number: 7090027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8.; HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8.