MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS COUPLING SCREW; EXTRACTOR

Model Number	338.31
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on unknown date that dhs/dcs coupling screw was received as blind unit.Product code:338.310 , lot# 237p610.However, it couldn¿t be associated with a complaint or any other existing record.This report is for one (1) dhs/dcs coupling screw 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.Occupation: reporter is a j&j employee.(b)(4).Part number: 338.310.Lot number: 237p610.Manufacturing site: (b)(4).Release to warehouse date: 22 juli 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual analysis of the returned sample revealed that the dhs/dcs coupling screw was broken from the distal tip, fragment was not returned.A dimensional inspection for the dhs/dcs coupling screw was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the dhs/dcs coupling screw would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition 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 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: DHS/DCS COUPLING SCREW
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15111580
• Report Number: 2939274-2022-02966
• Device Sequence Number: 19870957
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322
• 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

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: 338.31
• Device Catalogue Number: 338.31
• Device Lot Number: 237P610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/27/2022
• Date Device Manufactured: 07/22/2021
• 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