MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING

Model Number	03.114.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
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.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 when adjusting or tightening the screw, the screwdriver part broke.Concomitant device: unknown screw (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) stardrive screwdriver shaft t4/42mm/self-retaining.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.H3, h6: the complaint product is not available to return for investigation.The customer retaining the product.Device history lot part # 03.114.002, synthes lot # h346750, supplier lot # na, release to warehouse date: nov 17, 2017 , manufactured by synthes monument, no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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: STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10678630
• Report Number: 2939274-2020-04665
• Device Sequence Number: 2975741
• Product Code: HXX
• UDI-Device Identifier: 10886982072993
• UDI-Public: 10886982072993
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2020

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: 03.114.002
• Device Catalogue Number: 03.114.002
• Device Lot Number: H346750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020; 12/02/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.