MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL TRUESPAN ORTHOCORD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 228151

Device Problem Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

Event Type  malfunction  

Event Description

Truespan misfired and could not be used for implant.Obtained another truespan which was implanted without issue.Per surgeon's operative report - medial meniscus repair was original procedure.Next, we addressed the tear of the posterior horn medial meniscus.A probe was used to assess the tear, which revealed an unstable flaps in the central third that could be displaced into the joint.A combination of meniscal biters and the 4.0mm shaver were used to perform partial medial meniscectomy of approximately 1% of the meniscus.Only the inferior leaflet that was degenerative tissue was removed.Next, two mitek truespan all-inside sutures were placed in vertical mattress fashion to complete the menisco-capsular junction repair.Probe assessment of the meniscus demonstrated stability throughout the extent of the remaining tissue.

• Brand Name: TRUESPAN ORTHOCORD
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; depuy, inc.; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 8270148
• MDR Text Key: 133860567
• Report Number: 8270148
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: (01)10886705026012(17)210228(10)775663
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 775663
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 113