MAUDE Adverse Event Report: DEPUY MITEK LLC US ACL ACC DISPOSABLES KIT *EA; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Model Number	232300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was unknown; therefore, the manufacturing site name was unknown.(01)10886705011117(10)incomplete.The lot number was unknown.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
It was reported by the customer that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2021, it was observed that a nitinol wire sheered off while implanting the interference screw on the acl acc disposables kit device.According to the report, the broken wire was not noticed by anyone and was not seen when taking final visualization of the acl.It was reported that the patient came to see the surgeon after surgery complaining of knee pain and an xray confirmed there was a piece of wire inside the joine.It was reported that a follow up procedure had to be done to retrieve the retained broken wire.The current status of the patient was unknown.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 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: investigation summary: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (8l16832), and no non-conformances were identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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 to which this complaint is observed in the field.
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: b5: subsequent follow-up with the customer, additional information was received regarding the event.It was reported that during a left knee arthroscopy & acl repair the guidewire, approximately 6.5cm broke and remained in the patient's knee.This event was not discovered until the patient's first post operative appointment where an x-ray was completed and the foreign body was discovered.The patient was then rescheduled for a knee arthroscopy and foreign body removal.During the procedure, the patient tolerated the procedure well.The guidewire was removed without resistance.The surgeon stated that the patient did not have post operative complaints of pain outside of normal parameters of the patient's surgery.

• Common Device Name: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13252831
• Report Number: 1221934-2022-00170
• Device Sequence Number: 4585367
• Product Code: LXH
• UDI-Device Identifier: 10886705011117
• UDI-Public: 10886705011117
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 232300
• Device Catalogue Number: 232300
• Device Lot Number: 8L16832
• 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: 01/08/2022
• Supplement Date Received by Manufacturer: 01/17/2022; 02/01/2022; 01/06/2023
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 01/18/2022; 02/02/2022; 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male