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

Model Number	299704310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for expedium tab breaker, body was conducted identifying that lot number pu118687 was released in a single batch.Batch1: lot qty of (b)(4) units were released on may 23,2017 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.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the expedium tab breaker, body (part # 299704310 / lot # pu118687) was received at us customer quality (cq).The device was received with the leaf spring of the device missing from the assembly.Based on device assembly, the leaf spring was welded onto the tip.Since the tip was missing, it can be deduced that the weld failed thus the device was deemed broken.Magnification shows a fracture surface consistent with device breakage.The reported condition of missing components was confirmed as the weld failed.Device failure/defect identified? yes; weld failure.Leaf spring broke off the tip.Dimensional inspection: dimensional inspection was not performed as internal components were not accessible and the relevant fragment was not returned.Document/specification review: drawing(s) reviewed current & manufactured revisions.Conclusion: the overall complaint 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 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 synthes reports an event in (b)(4) as follows: it was reported that on an unknown date, prior to use on a patient, the verse tab breaker had no spring clip and flap to retain tabs.There was no patient consequence.Upon investigation findings, this complaint became reportable as a malfunction on (b)(6) 2020.This report involves one (1) expedium spine system tab breaker, body.This is report 1 of 1 for (b)(4).

• 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: 10391215
• Report Number: 1526439-2020-01453
• Device Sequence Number: 3668892
• Product Code: LXH
• UDI-Device Identifier: 10705034467375
• UDI-Public: (01)10705034467375
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: PU118687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1