MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC MALLEABLE GRAFT RETRACT *PK/5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 232024

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

This is report 1 of 2 for (b)(4).It was reported by a healthcare professional in switzerland that two malleable graft retractor devices did not have ce mark.There was no procedure nor patient involvement 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.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.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.

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.Device was used for treatment, not diagnosis.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary
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> a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.The complaint reported product code (b)(4) which corresponds to drawing for mitek component.In reviewing the picture provided by the customer with the manufacturing and supplier quality teams, it was determined that device in photo without the ce mark corresponds to drawing for mitek component and therefore the two devices without the ce mark are not the same part number reported in this complaint.Upon review of the appropriate design drawings, there was not a requirement for the device to be etched with the ce mark.It was also identified in reviewing receiving inspection reports, that last lot received was in 2013 and the longest shelf life for the product is 5 years.Based on this information, the devices are found to be conforming to the drawing at the time they were manufacturing and the complaint cannot be confirmed.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.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.Correction: d9: in was inadvertently reported in follow up medwatch report that the device was returned.It was determined that the device was not returned on (b)(6) 2023.

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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary : two devices were received and evaluated.On visual inspection, it was found that the returned devices does not correspond to the part number reported (232024_rapidloc malleable graft retract.The part number for the returned devices is 100043_malleable graft retractor.Given that lot number was not provided, the 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 investigation findings, the reported complaint was not confirmed.The customer reported product code 232024 which corresponds to drawing for mitek component.By reviewing the photo provided by the customer with the manufacturing and supplier quality teams, it was determined that received devices without the ce mark corresponds to drawing for mitek component and therefore the two devices without the ce mark are not the same part number reported in this complaint.Upon review of the appropriate design drawings, there was not a requirement for the device to be etched with the ce mark.It was also identified in reviewing receiving inspection reports, that last lot received of p/n 100043 was in 2013 and the longest shelf life for the product is 5 years.Based on this information, the devices are found to be conforming to the drawing at the time they were manufactured.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.

• 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: 17879002
• MDR Text Key: 325018649
• Report Number: 1221934-2023-03651
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705010967
• UDI-Public: 10886705010967
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 232024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1