MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM TAB BREAKER, BODY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704310
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
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.Reporter is a synthes employee.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 during a procedure, the tap breaker broke the engagement of the distal part when the doctor was breaking the tabs of the expedium verse screw.The procedure was completed successfully with no delay.There was no patient consequence.This report is for an expedium tab breaker, body.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the expedium tab breaker, body (part # 299704310 / lot # pu114251) was received at us cq.The device was received with the leaf spring of the device separated from the assembly.Based on device assembly, the leaf spring was welded onto the tip.Since the tip was separated, it can be deduced that the weld failed thus the device was deemed broken.Magnification shows a fracture surface consistent with device breakage.Was confirmed for the received expedium tab breaker, body as the weld connecting the leaf spring to the tip failed thus the device was broken.Although no definitive root-cause can be determined its possible the device experienced unintended forces.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 history lot: a review of the receiving inspection (ri) for verse 3in1 driver, outer shaft was conducted identifying that lot number pu114251 was released in a single batch.Batch1: lot qty of units were released on 12 dec 2016 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history batch: null.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: EXPEDIUM TAB BREAKER, BODY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11179049
• Report Number: 1526439-2021-00162
• Device Sequence Number: 2870556
• Product Code: LXH
• UDI-Device Identifier: 10705034467375
• UDI-Public: (01)10705034467375
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• 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: 299704310
• Device Catalogue Number: 299704310
• Device Lot Number: PU114251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/16/2021
• 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: UNKNOWN SCREWS