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

Model Number 228151

Device Problems Break (1069); Crack (1135); Loose or Intermittent Connection (1371); Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during meniscal suturing procedure performed on (b)(6) 2020.The needle was situated at a different direction.The device was brand new and the first use when the issue occurred.The complaint device was not received in its original package and inspected.The implants and suture were received along with the needle.The one implant seems to be release.It was identified that the sleeve was slightly damage, it was cracked in the distal part.When test its functionality, it was also observed that the trigger was loose, in that there was no tension on the handle from the spring, the internal mechanism of the trigger has been broken and disconnected from the firing spring.The needle was compared with another new device and there no anomalies found it.Based on the received condition of the needle and there no more information about this failure, this complaint cannot be confirmed, and we cannot discern a specific root cause for this issue reported.The possible root cause for the deployment failure could be related when not inserting the needle to the proper depth for deployment which have caused that the implant to not be deployed as intended.For the condition in the trigger, sleeve and implants, it is related to a rough deployment causing damage.It is possible that when fire the implant against the tissue, excessive force could have caused stress on the handle thus causing the handle mechanism to break.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number:3l49884, a no non-conformances was identified (nr-0113925) and it is not related to the reported complaint condition.

Event Description

It was reported by the affiliate in (b)(6) that during meniscal repair procedure on (b)(6) 2020, it was observed that the anchor device was situated in a different direction.During in-house engineering evaluation, it was determined that the sleeve on the anchor device was cracked in the distal part.It was also determined that the trigger was loose during functionality test; and that there was no tension on the handle from the spring.It was also determined that the internal mechanism on the trigger had been broken and disconnected from the firing spring; thereby, not inserting the needle to the proper depth for deployment which have caused that the implant to not be deployed as intended.The procedure was delayed for 30 minutes.There were no adverse patient consequences.The device was brand new and the first use when the issue occurred.No additional information could be provided.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 10854374
• MDR Text Key: 216962279
• Report Number: 1221934-2020-03520
• 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
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 3L49884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1