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	07/25/2022
Type of Reportable Event	Malfunction
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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2022, that while prepping the pedicle pathway with a straight thoracic pedicle probe at l5 on the left side, the tip broke off.The instrument may have been experiencing some fatigue at the junction of the tip and shaft.No harm was done and a new instrument was used in its place.As well, two expedium reduction instruments were not working properly as the threads seemed to be stripped and were unable to thread into the reduction sleeve.Over time the threads and these instruments do wear done and strip.These reduction instruments have been in circulation for a very long time and are probably due to be replaced due to regular wear and tear.Surgery was not delay a replacement instrument was brought in and the broken instrument was set aside., the surgery was successfully completed.Fragments were not generated.There was no patient outcome/consequences.This report is for one (1)approximator flex-clip.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part # 279712570.Lot # 0810nt.Supplier: norwood medical batch1: lot unit were released on 8 feb 2012 with no discrepancies.Batch2: lot unit were released on 1 feb 2012 with no discrepancies batch3: lot unit were released on 15 jun 2011 with no discrepancies.Batch4: lot unit were released on 18 may 2011 with no discrepancies batch5: lot qty unit were released on 17 may 2011 with no discrepancies.No non-conformance reports were generated during production.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 product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the threads inside of approximator flex-clip was worn.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed threads worn of approximator flex-clip would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed: the following document was reviewed: windchill.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 ; 3035526892
• MDR Report Key: 15278303
• Report Number: 1526439-2022-01447
• Device Sequence Number: 6485610
• Product Code: LXH
• UDI-Device Identifier: 10705034198996
• UDI-Public: (01)10705034198996
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup

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: 0810NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XPDM THORACIC PEDICLE PRB, ST
• Patient Sex: Unknown