MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RIGIDLOOP ADJUSTABLE DISPOSABLE KIT; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Model Number	218034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
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.Additional narrative: udi: (b)(4).The lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.Reporter is a j&j sales representative.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the sales rep that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that two rigidloop adjustable disposable kit devices broke at the same point (10mm).The procedure was completed with a 4.5 mm reamer with an unspecified slight delay.There were no adverse patient consequences 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 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.H10 additional narrative: d4, h4: the lot number, expiration date, and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi:(b)(4).
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.Investigation summary : the complaint devices are not being returned, they were discarded, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the device was observed broken at near the tip; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 9l19508, and no nonconformances were identified.The photo does not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer the possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure., however, this cannot be conclusively determined.Further, a review into the mitek complaints system revealed no other complaints for this lot of (b)(4) devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: RIGIDLOOP ADJUSTABLE DISPOSABLE KIT
• Common Device Name: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15543980
• Report Number: 1221934-2022-03024
• Device Sequence Number: 20476959
• Product Code: LXH
• UDI-Device Identifier: 10886705024070
• UDI-Public: 10886705024070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: 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 Model Number: 218034
• Device Catalogue Number: 218034
• Device Lot Number: 9L19508
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/17/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/13/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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