MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228151

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by affiliate via email that during an unknown procedure, while using a truespan meniscal repair system peek 12 degree, when the point was to be made with the suture, the implant trigger was pulled once and two points came out at the same time, so implant could not be used correctly.No surgical delay or patient consequence reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information provided, it was reported that during an unknown procedure, while using a truespan meniscal repair system peek 12 degree, when the point was to be made with the suture, the implant trigger was pulled once and two points came out at the same time, so implant could not be used correctly.Upon visual inspection of the photo, it was observed only the suture and the truespan gun.The silicone sleeve was broken nearest the needle.Besides, the suture is frayed on the distal.Since the truespan gun was not returned, it is not possible to test its functionality.The photo not provide evidence of the defective into device, therefore the complaint reported cannot confirmed.However, it cannot be determined at what point in time this failure occurred.As a result, we cannot determine a root cause for the reported failure.The possible root cause for the suture damage can be related to rough deployment causing that it had to be cut and remove; thus, it cannot be conclusively affirmed.Hands on analysis should provide more evidence to be able to discern a root cause.A manufacturing record evaluation was performed for the finished device lot number:6l43462, 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.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10155678
• MDR Text Key: 205990945
• Report Number: 1221934-2020-01553
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 6L43462
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2020
• Patient Sequence Number: 1