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

Catalog Number	223747
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4)- incomplete.The expiration date is not currently available.Associated medwatch: 1221934-2018-51268.
Event or Problem Description
It was reported by our affiliate that the reported product was used for the acl reconstruction by tensioning to the semitendinosus muscle on (b)(6) 2018.It was reported that the suture was detached when the adjustable suture was inserted to the bone hole.The adjustable suture could not apply enough tension to the semitendinosus muscle.The surgery was completed by inserting the anchor to opposite side of the graft.It was brand new and the first use when the issue occurred.There was less than 30 min.Surgical delay and no harm to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported that the suture left a loose fixture.No further information regarding the procedure, patient condition or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.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.Udi: (b)(4).Associated med watch : 1221934-2018-51268.

• Brand Name: SPEEDTRAP WHITE 30MM
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 7566941
• Report Number: 1221934-2018-51270
• Device Sequence Number: 2063204
• Product Code: GAT
• UDI-Device Identifier: 10886705027149
• UDI-Public: 10886705027149
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 12/31/2022
• Device Catalogue Number: 223747
• Device Lot Number: L658542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1