MAUDE Adverse Event Report: DEPUY SPINE INC APPROXIMATOR FLEX-CLIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279712570
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2022, the scrub nurse was putting together the modified reducers (from the loan modified expedium 5.5 reduction sleeve tray) at the beginning of the case and the reducer x25 driver became stuck mid way down the reduction sleeve.In total there were 4 pairs that became stuck.Scrub nurse was unable to remove them.The surgery was not delayed due to the reported event.The procedure was successfully completed.No patient consequences reported.This report is for (1) approximator flex-clip.This is report 7 of 8 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the approximator flex-clip appears to be in an assembled condition.Since the device was not returned for physical examination, the disassemble condition can not be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for approximator flex-clip.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: APPROXIMATOR FLEX-CLIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 14600641
• Report Number: 1526439-2022-00794
• Device Sequence Number: 6113542
• Product Code: LXH
• UDI-Device Identifier: 10705034198996
• UDI-Public: 10705034198996
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 279712570
• Device Catalogue Number: 279712570
• Device Lot Number: APAU0558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female