MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC MALLEABLE GRAFT RETRACT *PK/5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	232024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
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 mitek or its employees that the report constitutes an admission that the device, 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.D4, h4, udi: the lot number was unknown; therefore, the device manufacture date and expiration date are currently unavailable.Therefore, the udi is incomplete.Investigation summary : the product has not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that rapidloc malleable graft retract *pk/5 was inside of the instruments tray, however, the reported condition could not be clearly observed and no observations pertaining to the nature of the reported event could be identified.The overall complaint was unconfirmed as the observed condition of the rapidloc malleable graft retract *pk/5 would not contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during the procedure.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 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.
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was discovered that the rapidloc malleable graft retract *pk/5 device was used to initiate the meniscal suture.The doctor folded it to facilitate better suture entry, but when it was straightened again, it broke into two pieces.It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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 mitek or its employees that the report constitutes an admission that the device, 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.Updated device evaluation: additional photos were provided for review; therefore, the investigation has been revised with the following findings: investigation summary : the product has not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that rapidloc malleable graft retract pk/5 was inside of the instruments tray, however, the reported condition could not be clearly observed and no observations pertaining to the nature of the reported event could be identified.The review of the additional photos provided on november 6 revealed that the device was broken in two pieces near the middle part.The overall complaint was confirmed as the observed condition of the rapidloc malleable graft retract pk/5 would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during the procedure.As per ifu, inspect for damage prior to use.Replace a damaged, worn, or bent instrument.Do not attempt to straighten, sharpen, or repair.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 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.H6.Investigation findings, investigation conclusions and component codes have been updated accordingly.

• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20587859
• Report Number: 1221934-2024-03908
• Device Sequence Number: 17783971
• Product Code: LXH
• UDI-Device Identifier: 10886705010967
• UDI-Public: (01)10886705010967(10)INCOMPELTE
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 232024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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