MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STERILE LATARJET SCREW, 34MM; SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE

Model Number	288225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the sales rep in sweden that during an unknown procedure on an unknown date, a sterile latarjet screw, 34mm and a sterile latarjet screw, 36mm devices were used.According to the report, both screws were found broken at postop x-ray approximately five weeks after the surgery.It was further reported that the patient underwent a severe epileptic attack, hence the trauma leading to breakage of the screws.It was reported that a revision surgery was planned.It was reported that the patient had not received medical nor surgical treatments for the broken screws but increased medical pain relievers.The 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 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.Udi: (b)(4).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.
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 asappropriate.Investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation, however two bone scan images were provided.Upon visual inspection of the images, it can be observed the screws broken and away from the original position.A manufacturing record evaluation was performed for the finished device 9l37835 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to the epileptic attack the patient had.As per ifu 133314; until firm bone union is achieved, the patient should restrict physical activities which would place stress upon the devices.Detailed written instructions on such limitations should be given to the patient.The patient must be warned that complications such as bending or breakage of the device may occur as a result of weight bearing or muscle activity, however this cannot be conclusively determined.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.

• Brand Name: STERILE LATARJET SCREW, 34MM
• Common Device Name: SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): 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: 16684106
• Report Number: 1221934-2023-01495
• Device Sequence Number: 17967489
• Product Code: HWC
• UDI-Device Identifier: 10886705027026
• UDI-Public: 10886705027026
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K110763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Model Number: 288225
• Device Catalogue Number: 288225
• Device Lot Number: 9L37835
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown