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

Catalog Number	223749
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
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 was discarded and not available for evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part (223749), lot (l193694) combination and no non-conformances were identified.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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).Associated medwatch: 1221934-2018-55793.
Event or Problem Description
It was reported that during an acl repair the surgeon tried to use speed trap but 4 of the devices malfunctioned.There are no patient consequences.The information being submitted for this complaint all the details that are known/available regarding this event.Additional information received on 12/14/18 from sales representative stating: the facility name and address.The product being reported was being used during an acl reconstruction.The failure with the (2) product code: 223749 - suture pulled off the plastic part of device before it could be fully pulled onto the graft.The procedure was completed by using the arthrex fiberloop.There were no delays or patient consequences.

• 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: 8185784
• Report Number: 1221934-2018-55794
• Device Sequence Number: 2792062
• Product Code: GAT
• UDI-Device Identifier: 10886705027163
• UDI-Public: 10886705027163
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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: 11/30/2021
• Device Catalogue Number: 223749
• Device Lot Number: L193694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1