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

Model Number 228161

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Additional narrative: patient codes: "no code available" used to report "surgical intervention".Udi: (b)(4).The expiration date is unknown at this time.

Event Description

It was reported by the sales rep via phone that six weeks after a anterior cruciate ligament reconstruction with meniscal repair procedure the patient heard a pop on the leg.An mri was performed and another radial tear was confirmed in the lateral meniscus.An additional procedure will be scheduled to repair the new tear.The devices are still implanted in the patient´s body.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for he initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.Multiple follow ups were performed to obtain more information but no response was received.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported event.A manufacturing record evaluation was performed for the finished device lot number (6l75729), and no non-conformances were identified.If any additional information is obtained, this complaint will be re-opened to capture that information.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 PLGA
• 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: 10487515
• MDR Text Key: 205473317
• Report Number: 1221934-2020-02378
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026043
• UDI-Public: 10886705026043
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 228161
• Device Catalogue Number: 228161
• Device Lot Number: 6L75729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Patient Sequence Number: 1