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

Model Number	223747
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep in hong kong that during an unknown procedure on (b)(6) 2023, it was observed that the speedtrap construct  white, long device was damaged at the end of the graft that caused the graft to break.During in-house engineering evaluation, it was determined that the winding white suture on the device was frayed and broken.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.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: udi: (b)(4).E3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.Investigation summary: the device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations reveals that the winding white suture was frayed and broken, no anomalies were found in the speedtrap delivery.A manufacturing record evaluation was performed for the finished device lot number: 110l856, and no nonconformances were identified.Based on the condition of the suture, this complaint can be confirmed, but a root cause cannot be established.The possible root cause can be related to procedural variables, such handling of the device or product interaction during procedure.The condition of the suture could be related to an under over tension exerted on the white loop shortening suture resulting compromise the integrity of the suture/graft construct, moreover, it is possible that an instrument used in the procedure caused fraying on the suture and then broken.As per ifu, as with other suture tensioning techniques, avoid under-tensioning the speedtrap winding sutures; otherwise, laxity of the speedtrap suture/graft construct may result.Similarly, avoid over-tensioning as this may compromise the integrity of the speedtrap suture/graft construct.Apply axial tension to the graft while pulling each winding suture limb until all suture loops are tight around the graft.As with other suture materials, adequate knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator.Avoid damage to the device or sutures when handling.Avoid crushing or crimping damage caused by application of surgical instruments, such as forceps or graft preparation board clamps.Do not use the speedtrap suture construct on individual graft diameters smaller than 2mm.Do not manipulate sutures prior to use.Do not trim graft ends less than 3mm from the distal whip stitch; the suture construct may slip off the graft end.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: SPEEDTRAP CONSTRUCT WHITE, LONG
• Common Device Name: POLYETHYLENE SUTURE
• 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: 16763312
• Report Number: 1221934-2023-01680
• Device Sequence Number: 6106013
• Product Code: GAT
• UDI-Device Identifier: 10886705027149
• UDI-Public: 10886705027149
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 223747
• Device Catalogue Number: 223747
• Device Lot Number: 110L856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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