MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RIGIDLOOP PASSING PIN 2.4MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	232025
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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.H10 additional narrative: udi:(b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.E3: reporter is a j&j employee.Investigation summary = > the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observation reveled that the pin was found inside the cannula, it was not possible to disassembled it.Also the pin shows marks of wear as well as scratches, it was found broken, the broken piece was not returned.The pin tip does not show structural anomalies.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection results, this complaint can be confirmed.The possible root cause for the device broken condition can be related to procedural variables, such handling of the device or product interaction during procedure; an excessive force could have been applied to the pin and consequently cause the pin to break, also; the continuous use and sterilization process can cause wear and consequently the device damage, however this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
This is report 3 of 3 for (b)(4).It was reported by the affiliate in belgium that the rigidloop passing pin 2.4mm device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the pin was found broken; and the broken piece were not returned.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: RIGIDLOOP PASSING PIN 2.4MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17436687
• Report Number: 1221934-2023-02885
• Device Sequence Number: 6770421
• Product Code: LXH
• UDI-Device Identifier: 10886705022748
• UDI-Public: 10886705022748
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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: 232025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown