MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SPEEDTRAP CONSTRUCT WHITE, SHORT; POLYETHYLENE SUTURE

Model Number	223746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
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 employee.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 affiliate in japan that during an anterior cruciate ligament reconstruction procedure on an unknown date, a speedtrap construct  white, short device was used.According to the report, one month after surgery, inflammation and fever occurred in the knee joint.It was reported that when the inflamed synovium was removed by arthroscope, there was a lot of synovial membrane around the device.It was reported that there are no abnormalities when it was sent to pathology for now.It was reported that although there were signs of infection, it could be ruled out as a complete infection.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.B3, b5: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the date of event and event description have been updated accordingly.D4: the lot number and expiration date were unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).
Event or Problem Description
It was reported by the affiliate in japan that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2023, a speedtrap construct white, short device was used.According to the report, one month after surgery, inflammation and fever occurred in the knee joint.It was reported that when the inflamed synovium was removed by arthroscope, there was a lot of synovial membrane around the device.It was reported that there are no abnormalities when it was sent to pathology for now.It was reported that although there were signs of infection, it could be ruled out as a complete infection.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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.Since the complaint device was implanted, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (9l19604), and no non-conformances were identified.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: SPEEDTRAP CONSTRUCT WHITE, SHORT
• Common Device Name: POLYETHYLENE SUTURE
• 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: 16765119
• Report Number: 1221934-2023-01706
• Device Sequence Number: 6106068
• Product Code: GAT
• UDI-Device Identifier: 10886705027132
• UDI-Public: 10886705027132
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 223746
• Device Catalogue Number: 223746
• Device Lot Number: 9L19604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 06/14/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/24/2023; 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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