MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	02.212.056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that screws from a locking compression (lcp) extraarticular distal humerus plating failed postoperatively.Based on the x-ray, it is evident that the screw heads were broken and the implant failed.According to surgeon, the patient does not wish to undergo a revision at this stage.The initial surgery was performed six weeks ago, and the patient was doing well.According to the patient, no external forces exerted on the implant caused it to move.No further information is provided.This report is for one (1) 3.5mm locking screw slf-tpng with stardrive recess 56mm this is report 3 of 10 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.Complainant part is not expected to be returned for manufacturer review/investigation.Photo investigation: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the locking screw stardriveâ® ã¿ 3.5 mm, self- had broken between the head and threaded shaft while still implanted in the patient's bone, several fragments are visible in the x-ray evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the locking screw stardriveâ® ã¿ 3.5 mm, self-.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.A manufacturing record evaluation cannot be performed since lot number is unknown.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: 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15214514
• Report Number: 2939274-2022-03217
• Device Sequence Number: 5542061
• Product Code: KTT
• UDI-Device Identifier: 10886982055217
• UDI-Public: (01)10886982055217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.212.056
• Device Catalogue Number: 02.212.056TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-; LOCKING SCREW STARDRIVE® ÿ 3.5 MM, SELF-
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown