MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS; EXTRACTOR

Model Number	309.521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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
It was reported that on unknown date, that the colonical extraction screw broke.Procedure outcome is unknown.No patient consequence.This report involves one (1) conical extraction screw for 3.5mm screws.This is report 1 of 1 for (b)(4).
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.H10 additional narrative: d11: additional concomitant device reported.H3, h4, h6: device history lot device history lot part: 309.521.Lot: l691951.Manufacturing site: bettlach.Release to warehouse date: 27.Feb.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: background: it was reported that on unknown date, that the colonical extraction screw broke.Procedure outcome is unknown.No patient consequence.This complaint involves one (1) device.Flow: damage.Visual inspection: the conical extraction screw for 3.5mm screws (part: 309.521; lot: l691951) was received at uscq.Upon visual inspection it was noticed that the tip's threaded part was noticed broken.No other defects were identified on the device.Defect was identified.Dimensional analysis: no dimensional analysis was performed due to confirmed post manufacturing damage identified.Document verification: se_240516 rev b and rev c.Complaint was confirmed.Conclusion: the complaint condition is confirmed.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11164463
• Report Number: 2939274-2021-00249
• Device Sequence Number: 845789
• Product Code: HWB
• UDI-Device Identifier: 10886982185839
• UDI-Public: (01)10886982185839
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 309.521
• Device Catalogue Number: 309.521
• Device Lot Number: L691951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/09/2021
• 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: CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS