MAUDE Adverse Event Report: DEPUY MITEK LLC US GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 219962

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

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 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 Description

This is report 2 of 2 for (b)(4).It was reported by sales rep via email that during anterior cruciate ligament repair graft prep board and slider unit did not slide onto the track while in use together.According to the report, both slider units from both ends were tried.It was further reported that they used the graft graspers in the stationary holes on the blue frame of the board to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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.Device was used for treatment, not diagnosis.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 product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.Upon visual inspection revealed that the device shows wear mark, no structural anomalies were found in the device.When performing the functional test, the device was placed on the preparation board and moved along the screw, difficult to advance due to resistance was felt when actioned along the board, however the device was able to advance.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.According with the visual inspection and the functional test result, this complaint can be confirmed.The possible root cause for the wear condition can be related to fair wear and tear due to age and use.However, it cannot be conclusively affirmed.As per ifu- (b)(4); inspect for damage prior to use.Replace damaged or worn instruments.Do not attempt to repair.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17471341
• MDR Text Key: 320514907
• Report Number: 1221934-2023-02958
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705007042
• UDI-Public: 10886705007042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 219962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 08/21/2023
• Supplement Dates FDA Received: 08/16/2023; 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1