MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SPEEDTRAP WHITE 30MM 4PK; POLYETHYLENE SUTURE

Catalog Number	223749
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 implanted in the patient, therefore, unavailable for a physical evaluation.No non-conformances were identified for this part number, lot number combination per qlik query executed on 5/3/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl and lcl reconstruction procedure, the speedtrap construct, green/white and the speedtrap construct, white broke while being shuttled through the tunnel.The sales rep stated that both sutures broke on the upper half near the speedtrap.A suture passer and a suture cutter were not used in this procedure.The sales rep stated the surgeon was using proper suture management.The surgeon salvaged the remainder of the both sutures and used them to complete the case.There was no patient harm or surgical delay.The sutures were implanted in the patient.

• Brand Name: SPEEDTRAP WHITE 30MM 4PK
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8600600
• Report Number: 1221934-2019-57118
• Device Sequence Number: 2193439
• Product Code: GAT
• UDI-Device Identifier: 10886705027163
• UDI-Public: 10886705027163
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 223749
• Device Lot Number: L736654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1