MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QA+ O/C DS CP-2 *EA; STAPLE, FIXATION, BONE

Catalog Number	222984
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: h4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the super qa+ o/c ds cp-2 *ea device broke when the surgeon pulled on the sutures of the anchor.According to the report, the surgeon first had trouble sliding the opening to release the wires from the anchor, and then when he pulled the wires, the anchor was torn off the bone.There was patient involvement.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the device received.The device was received for evaluation.Visual inspection revealed that the sutures, titanium anchor and needles were completely out of the device, they do not show structural anomalies.The titanium anchor does not show any broken area.The rest of the device was in a normal condition.Partial parts of the anchor show biological matter.A review of the batch manufacturing records was conducted on finished lot number 287l692: and no related non-conformances were identified.The overall complaint was unconfirmed as the observed condition of the super qa+ o/c ds cp-2 *ea would have not contributed to the complained device issue.Based on the investigation findings, and since no broken areas were detected in the anchor, it was conclude that there is no enough evidence to adjudicate a root cause for the issue experienced by the customer.Therefore, it has been determined that no corrective and/or preventative action is required.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.

• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20463676
• Report Number: 1221934-2024-03698
• Device Sequence Number: 7880343
• Product Code: JDR
• UDI-Device Identifier: 10886705008629
• UDI-Public: 10886705008629
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052631
• 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,User Facility,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: 222984
• Device Lot Number: 287L692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 11/15/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/13/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown