MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SPEEDTRAP GRN/WHITE 20MM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	223751
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.H11: additional narrative: h4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported from japan that during was an arthroscopic rotator cuff repair procedure for anterior cruciate ligament (acl) damage, it was discovered that the speedtrap grn/white 20mm device was removed from the body.During the surgery, it was reported that the speed trap was used on the ¿am¿ and ¿pl¿ bundles, respectively.After guiding both bundles into the body, tension was applied to each.Upon applying tension, the ¿pl¿ bundle, along with a portion of the graft, was removed from the body.The ¿pl¿ bundle graft was removed, and the graft, along with part of the original graft and the device, was re-sutured using different threads to form a new graft.This graft was then successfully guided back into the body, along with the device.There was thirty-minute delay to the surgical procedure.A spare device was used to complete the surgery successfully.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Device was used for treatment, not diagnosis.H4: the device manufacture date was unavailable in the initial medwatch report.The device manufacture date has been updated accordingly.Investigation summary the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (141l194), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: SPEEDTRAP GRN/WHITE 20MM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• 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: 20302321
• Report Number: 1221934-2024-03338
• Device Sequence Number: 8883536
• Product Code: GAT
• UDI-Device Identifier: 10886705027972
• UDI-Public: (01)10886705027972(10)141L194(17)280331
• 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
• Report Date (Section B): 09/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 223751
• Device Lot Number: 141L194
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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
• Patient Sex: Unknown