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

Catalog Number 228152

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

Event Description

It was reported that the needle broke while inserting the backstop.Another like device was used to complete the procedure.

Event Description

It was reported that the needle broke while inserting the backstop.Another like device was used to complete the procedure.Additional information from the affiliate 6/11/2018: did the breakage result in surgical delay of greater than 30 minutes or an inability to complete the procedure as intended? no.If breakage occurred near surgical site, how were fragments retrieved? the needle was still on the inserter.How was the procedure completed? with same like product.Were alternatives readily available? yes.Were there any procedural or patient anatomy factors which may have contributed to the breakage? small joint.Is surgical intervention planned? no.Did portion of the device remain in the patient? no any patient impact? no.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.Visual inspection confirms that the needle shaft of the truespan broke off.Thus, confirming this complaint.The implants and suture were both intact within the needle confirming no implants were deployed in the joint.The pusher rod was evaluated, via functional testing the trigger was pulled.A click was heard as intended, indicating the functionality of the device is sound.While fully pulling the trigger to expose the pusher rod, visually the pusher rod looked to be deformed.It was reported that the patient had a small joint which could¿ve made a difficult entry for the user, resulting in the excessive force used on the truespan device to get access to the meniscus.Other than these possibilities listed, a specific root cause cannot be determined.The dhr review indicated that this batch of devices was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices released to distribution.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).

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 7515526
• MDR Text Key: 108358401
• Report Number: 1221934-2018-50649
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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: 228152
• Device Lot Number: L649585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1