MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VERTEBRAL DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.820.112
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
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
It was reported that during an unknown procedure on november 10, 2020, the tip of the vertebral distractor broke off.It was recovered and took out of the patient.It is unknown if the procedure was completed successfully.There was no surgical delay reported.The patient outcome was unknown.This report is for one (1) vertebral distractor.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.H3, h4, h6: part 03.820.112, lot t921056: manufacturing site: tuttlingen.Release to warehouse date: march 28, 2008; april 10, 2008.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 12 years old).H3, h6: a product investigation was completed: upon visual inspection, it was observed that one of the jaws of the distractor was broken at its distal tip portion.The broken fragment was not returned.No other issues were identified with the returned device.Dimensional inspection showed the relevant dimensions were conforming.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.The complaint condition is confirmed.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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: VERTEBRAL DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10960631
• Report Number: 2939274-2020-05479
• Device Sequence Number: 16688790
• Product Code: LXH
• UDI-Device Identifier: 10705034731537
• UDI-Public: (01)10705034731537
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 03.820.112
• Device Catalogue Number: 03.820.112
• Device Lot Number: T921056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1