MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228152

Device Problems Migration or Expulsion of Device (1395); Device Contamination with Chemical or Other Material (2944)

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 7 for the same event.It was reported by the sales rep via phone that during a meniscal repair procedure, it was observed that the truespan meniscal repair peek 24 degree (lot: l775664) device deployed the first implant, but the implant pulled out.The sales rep's second truespan meniscal repair peek 24 degree (lot: l775664) needle depth was changed from 18 to 20, but the device deployed the first implant and then it pulled out from the patient.This same malfunction occurred with the sales rep's third (lot: l775664), fourth (lot: l668614) and fifth (lot: l690026) truespan meniscal repair peek 24 degree.The customer's truespan meniscal repair peek 12 degree (lot: l896423) and truespan meniscal repair peek 0 degree (lot: 854983) also deployed the first implant and then pulled out.The sales rep stated that the implants were removed from the patient with a grasper, but she stated there is an unknown number of backstops left in the patient.The sales rep stated there is no surgical intervention planned to remove the backstops.The case was completed with a competitor's device.The patient's meniscus was damaged from additional holes created from the implants and there was a fifteen minute delay to complete the case.The devices were discarded into the sharps container by the customer.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the complaint device was discarded by the customer, therefore, the device is not available for a physical evaluation.This complaint is not confirmed.The information provided is not sufficient to determine a root cause for the reported failure.Furthermore, a non-conformance search was performed for this part#: 228152, lot#: l668614 combination and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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 24 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: 7959913
• MDR Text Key: 123499083
• Report Number: 1221934-2018-54936
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 228152
• Device Lot Number: L668614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1