MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN MENISCAL REPAI SYSTEM PEEK 12 DEGREE; SOFT-TISSUE ANCHOR, BIO-ABSORBABLE

Catalog Number 228151

Device Problem Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.Associated medwatches: 1221934-2018-50411, 1221934-2018-50412.

Event Description

It was reported, that in two cases, the second implant fell out spontaneously from the needle without force being applied to the system.The seam had to be redone.In another case, the implants were triggered correctly, but the string could not be tightened reasonably.It is unknown if there were any patient consequences.The following information was obtained from the sales rep on (b)(6) 2018 via e-mail: i was in the hospital for another operation and these mentioned issues were reported to me from an or nurse in the corridor.So i did not support the operation where these issues happened and i only mentioned in the complaint what the or nurse told me.Therefore, unfortunately, i can neither provide you with more detailed information.Nor did the hospital store the truespan devices that caused these problems.These failures happened for three truespan different procedures for the same patient.There was only one patient involved.By different ¿cases¿ i meant the following two different types of failure that occurred: first issue (¿case¿): during the first two truespan procedures, the second implant was fallen out automatically.Second issue (¿case¿): during the third truespan procedure, the string could not be tightened reasonably.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.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, 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.Udi: (b)(4).Associated medwatches: 1221934-2018-50411, 1221934-2018-50412.

• Brand Name: TRUESPAN MENISCAL REPAI SYSTEM PEEK 12 DEGREE
• Type of Device: SOFT-TISSUE ANCHOR, BIO-ABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7397212
• MDR Text Key: 104717892
• Report Number: 1221934-2018-50414
• 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: 03/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 228151
• Device Lot Number: L642072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1