MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SPEEDTRAP GRN/WHITE 20MM; POLYETHYLENE SUTURE

Model Number	223751
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).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 (b)(4) that during an arthroscopic rotator cuff repair procedure on (b)(6) 2021, it was observed that the tendon snapped while in use with the speedtrap grn/white 20mm device.There were no adverse patient consequences reported.No additional information was provided.The device was brand new and its first use when the issue occurred.
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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (7l74440), and no non-conformance was 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.
Event or Problem Description
It was reported by the affiliate in japan that during an arthroscopic rotator cuff repair procedure on (b)(6) 2021, it was observed that the tendon snapped while in use with the rgdloop adjustable stnd device.Since the torn tendon could not be used, reconstructive surgery was performed using gracilis, with another like device to complete the procedure without delay.The status of the patient post-surgery was unknown.No additional information was provided.The device was brand new and its first use when the issue occurred.
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.H10 additional narrative: clinical and impact codes: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, all aforementioned fields have been updated accordingly.

• Brand Name: SPEEDTRAP GRN/WHITE 20MM
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12234090
• Report Number: 1221934-2021-02306
• Device Sequence Number: 5097240
• Product Code: GAT
• UDI-Device Identifier: 10886705027972
• UDI-Public: 10886705027972
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

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 Expiration Date: 01/31/2026
• Device Model Number: 223751
• Device Catalogue Number: 223751
• Device Lot Number: 7L74440
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 08/04/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 07/30/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention