MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM SELF-DRILLING SCHANZ SCREW 60MM THRD/175MM; SCREW,FIXATION,BONE

Model Number	294.785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year is reported as 2020; however exact date of event is unknown.Additional product code ktt.(b)(4).The investigation could not be completed, no product was received; 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
It was reported that on (b)(6) 2020, the patient underwent removal of external fixator and schanz screw.A self-drilling schanz screw broke after multiple weeks of being used as an external fixator.He procedure was successfully completed.There were fragments generated on the broken device but was able to remove all self-drilling schanz screw by hand in clinic without anesthesia due to patient's neuropathy.The patient is currently in a below the knee cast until definitive surgical correction.Concomitant devices reported: self-drilling schanz screw 80mm thrd/250mm (product code: 294.788, lot number: 61p2452, quantity: 2).This complaint involves four (4) devices.This report is for (1) 5.0mm self-drilling schanz screw 60mm thrd/175mm.This is report 2 of 2 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.Investigation summary: visual inspection: the 5.0mm self-drilling schanz screw 60mm thrd/175mm (p/n 294.785 lot 37p8767) was received showing the tip of the device chipped/broken on the edges.It was also noticed that the threaded portion was stripped.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post manufacturing damage of the tip.Document/specification review: the following drawing, reflecting the manufactured and current revision, were reviewed.Seldrill schanz screw, (manufactured) & (current).During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint condition is confirmed for the 5.0mm self-drilling schanz screw 60mm thrd/175mm (p/n 294.785 lot 37p8767) as the tip of the device was chipped which can be related to the broken condition.Also the threaded portion of the screw was stripped.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number: 294.785, lot number: 37p8767, manufacturing site: raron, release to warehouse: jan 29, 2020.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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: 5.0MM SELF-DRILLING SCHANZ SCREW 60MM THRD/175MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10852850
• Report Number: 2939274-2020-05191
• Device Sequence Number: 2322808
• Product Code: HWC
• UDI-Device Identifier: 10886982182166
• UDI-Public: (01)10886982182166
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K952296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 294.785
• Device Catalogue Number: 294.785
• Device Lot Number: 37P8767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM SELF-DRILLING SCHANZ SCREW 80MM THRD/250MM; 5.0MM SELF-DRILLING SCHANZ SCREW 80MM THRD/250MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86