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

Model Number	INTERNALBRACE LIGAMENT
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9141689
• Report Number: 1220246-2019-01337
• Device Sequence Number: 2852599
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: 00888867096080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other