MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER HANDLE HEX COUPLING-MEDIUM

Model Number	311.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: reporter is a j&j sales representative.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The device has been 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
Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date, the screwdriver handle collar do not close completely and not allowing the screwdriver blade to secure in the recess.No patient outcome was reported.This complaint involves one (1) device screwdriver handle hex coupling-medium.This is report 1 of 1 for complaint (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: investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the screwdriver handle hex coupling-medium.A dimensional inspection was not performed for the screwdriver handle hex coupling-medium due to the design of the device.A functional test could not be performed as the mating device was not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the screwdriver handle hex coupling-medium was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 review: a review of the device history records was performed for part number: 311.006, lot number: t931667; and no non-conformances were identified.

• Brand Name: SCREWDRIVER HANDLE HEX COUPLING-MEDIUM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14844439
• Report Number: 2939274-2022-02399
• Device Sequence Number: 4743979
• Product Code: HXX
• UDI-Device Identifier: 10887587035598
• UDI-Public: (01)10887587035598
• Combination Product (Y/N): N
• 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): 06/28/2022

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: 311.006
• Device Catalogue Number: 311.006
• Device Lot Number: T931667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown