MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SPEEDTRAP GRN/WHITE 30MM; POLYETHYLENE SUTURE

Model Number	223748
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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.Udi: (b)(4).
Event or Problem Description
The extremity of the wire was attached to the cap of the packaging during the sealing.
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: investigation summary: according to the information provided, it was reported on left knee ligamentoplasty procedure, that the extremity of the wire was attached to the cap of the packaging during the sealing.Only the speedtrap grn/white 30mm device was received and evaluated.Visual observations reveal the packaging was not received along with the device.In addition, the suture was intact, due to was not presented any physical damages and was in place inside of the device.Since of the condition of the device received this complaint cannot be confirmed.The possible root cause for the reported failure can be occurred during handling or transportation.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number:5l45441, 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.
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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Additional information: b4: the date of event was reported as unknown on the initial report; and has been updated accordingly.B5: subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during a knee ligamentoplasty procedure.There was no delay as another like-device was used to complete the surgery.There were no adverse patient consequences reported.

• Brand Name: SPEEDTRAP GRN/WHITE 30MM
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10708534
• Report Number: 1221934-2020-03098
• Device Sequence Number: 16909148
• Product Code: GAT
• UDI-Device Identifier: 10886705027156
• UDI-Public: 10886705027156
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 223748
• Device Catalogue Number: 223748
• Device Lot Number: 5L45441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 12/17/2020; 12/29/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 10/26/2020; 12/18/2020; 12/30/2020
• Patient Sequence Number: 1