MAUDE Adverse Event Report: DEPUY SPINE INC APPROXIMATOR FC SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	279712580
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on august 13, 2024, several expedium instruments were broken or had a malfunction.The straight probe had a tip bent.The straight feeler was broken.A torque driver tip was stripped.A reducer, clip and sleeve had threads stripped and both pieces stuck together.No surgical delay.Procedure was completed successfully.New devices provided.This report is for one sleeve 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.H6: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the approximator flex-clip is stuck with the approximator fc sleeve, the sleeve is embedded inside approximator fc sleeve, where it can be seen that the threaded areas of both devices no longer rotate.Its reasonable to conclude that this condition may cause due to stripped condition.Therefore, the reported condition can be confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional evaluation was performed, and the instruments were jammed.They could not be rotated, inserted or removed.The overall complaint was confirmed as the observed condition of the approximator fc sleeve would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.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) approximator fc sleeve , was conducted identifying that lot number was nw145917 released in one batch.Batch 1: lot qty of (b)(4) units were released on 05 apr 2014 jan with no discrepancies.Supplier; (b)(4).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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APPROXIMATOR FC SLEEVE
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 20171451
• Report Number: 1526439-2024-02316
• Device Sequence Number: 8069754
• Product Code: GEA
• UDI-Device Identifier: 10705034199009
• UDI-Public: (01)10705034199009(11)140405(10)NW145917
• 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,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 Catalogue Number: 279712580
• Device Lot Number: NW145917
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/24/2024; 10/04/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/25/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown