MAUDE Adverse Event Report: ARTHREX, INC. INTERNALBRACE LIGAMENT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number INTERNALBRACE LIGAMENT

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

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not been returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the patient had a primary brostrum repair done on (b)(6) 2018 in which the ar-1688-cp internal brace implant system (lot: 10224042) was used.The patient was cleared by the surgeon in (b)(6) of 2019 after the procedure.In (b)(6) of 2019 the patient returned for a follow-up, and the x-rays taken revealed bone loss around the site of the implanted anchors.A revision procedure was performed on (b)(6) 2019.The rep stated during the revision procedure all implant components from the ar-1688-cp system were removed from the patient whole and in tact.The surgeon took cultures and samples, and removed fluid from the ankle.The culture results revealed no infection found.The patient did not test positive for anything, and the culture results are available.The rep confirmed the primary and revision procedure took place at the same facility, and were performed by the same surgeon.Additional information received on (b)(6) 2019: the rep stated they were present for both the primary and revision procedure.Arthrex device ar-1688-cp (lot: 10224042) was implanted during the revision procedure.The bone quality was medium, the bone was prepped per the technique guide.The surgeon used the k-wire and over-drilled with the 2.7 drill bit, tapped the talus and inserted 4.75 swivelock into talus.The surgeon then used the k-wire to ensure placement into the fibula and overdrilled it as well with 2.7.The surgeon did not tap the fibula, and then placed the 3.5 swivelock in.The rep stated they are still have not received the culture results from the surgeon.

Manufacturer Narrative

This submission also contains additional information regarding culture results.Complaint confirmed.A possible cause for bone loss around the anchor is osteolysis due to a reaction to the material implanted.Improper bone prep may also result in damage to the bone.The eyelet was also found to be damaged.Likely causes include improper bone prep, misaligned insertion.

Event Description

It was reported that the patient had a primary brostrum repair done on (b)(6) 2018 in which the ar-1688-cp internalbrace implant system (lot: 10224042) was used.The patient was cleared by the surgeon in (b)(6) 2019 after the procedure.In (b)(6) 2019 the patient returned for a follow-up, and the x-rays taken revealed bone loss around the site of the implanted anchors.A revision procedure was performed on (b)(6) 2019.The rep stated during the revision procedure all implant components from the ar-1688-cp system were removed from the patient whole and in tact.The surgeon took cultures and samples, and removed fluid from the ankle.The culture results revealed no infection found.The patient did not test positive for anything, and the culture results are available.The rep confirmed the primary and revision procedure took place at the same facility, and were performed by the same surgeon.Additional information received on 09/24/2019: the rep stated they were present for both the primary and revision procedure.Arthrex device ar-1688-cp (lot: 10224042) was implanted during the revision procedure.The bone quality was medium, the bone was prepped per the technique guide.The surgeon used the k-wire and overdrilled with the 2.7 drill bit, tapped the talus and inserted 4.75 swivelock into talus.The surgeon then used the k-wire to ensure placement into the fibula and overdrilled it as well with 2.7.The surgeon did not tap the fibula, and then placed the 3.5 swivelock in.The rep stated they are still have not received the culture results from the surgeon.Additional information received on 10/2/2019: the rep provided a copy of the final culture results.Results were negative.The received file has been attached into the arthrex case record.

• Brand Name: INTERNALBRACE LIGAMENT
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9141689
• MDR Text Key: 163122698
• Report Number: 1220246-2019-01337
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: 00888867096080
• Combination Product (y/n): N
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: INTERNALBRACE LIGAMENT
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: 10224042
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other