MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO SUTURE MANIP *EA; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Catalog Number	214626
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: investigation summary- the product and a photos were returned to depuy synthes for evaluation.Visual inspection of the returned photos found the device shaft deformed at the distal end.No other anomalies were noted.Visual inspection of the returned device found that the tip was deformed.No other anomalies were noted.The manufacturer performed an investigation of the device returned with the following results: the device was found to be bent, which correlates with the customer¿s complaint description.A functional deviation was identified as a result of the device¿s bent condition.The investigation was conducted by a cross-functional team comprising representatives from engineering, production, quality control, and quality assurance.The findings presented reflect their collective assessment.The device history records (dhr) were reviewed and found to be complete, with no discrepancies reported or observed during production.The in-process and final inspections were conducted according to device master record (dmr) requirements with no deviations observed or recorded.The final inspection of the finished goods includes a 100% visual inspection of the devices.All units passed inspection with no deviations observed or recorded.The device is classified as reusable, non powered surgical instrument.The ifu ¿caution¿ section clearly states to inspect the device for damage prior to use.Replace a damaged, worn or bent instrument.Do not attempt to straighten, sharpen or repair.Transportation and shipping activities at tag are carried out by externally qualified courier companies.The likely root cause appears to be damage resulting from transportation or shipping process carried out by external courier, or by improper storage conditions at the customer site.The overall complaint was confirmed as the observed condition of the arthro suture manip *ea would have contributed to the complained issue.¿ based on the investigation findings, a potential cause could be traced to transport/storage.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 depuy synthes 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 manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.
Event or Problem Description
It was reported that after preparing the new ancillary tools for the rotator cuffs, and when opening the packaging of the arthro suture manip device it was observed that the device was bent in the packaging.During in-house engineering evaluation it was determined that the tip of the device was deformed.It was not reported if the event occurred during a surgical procedure.There were no reported adverse consequences to the patient.No additional information could be provided.

• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24272832
• Report Number: 1221934-2026-00582
• Device Sequence Number: 13429268
• Product Code: HCF
• UDI-Device Identifier: 10886705004089
• UDI-Public: (01)10886705004089(10)25E01
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• 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 Catalogue Number: 214626
• Device Lot Number: 25E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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 Sex: Unknown