MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMP-TENO SWIVELOCK, 6.25 X 15, VE5; SCREW, FIXATION, BONE

Model Number	BIOCOMP-TENO SWIVELOCK, 6.25 X 15, VE5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
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 not returned for evaluation.The device was reported to have been discarded.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 bonesync, abs-3103, was being used in an ankle case.The patient had a previous calcaneal fracture, that was again refractured at the insertion site of the achilles tendon.The large fragment was pinned and patient returned for repair of the achilles¿ tendon.Patient has a history of smoking.After insertion of the first anchor of the speedbridge implant system, the anchor pulled out due to very poor bone quality.The surgeon increased the size of the anchor to a 5.5 swivelock, but ultimately, it still pulled out.At this point, the rep recommended the use of bone sync.After quick approval from the facility, the rep retrieved 3cc of bonesync, abs-3103.He reviewed the indications and technique provided by arthrex and after discussing with the doctor and due to time sensitivity (patient was on the table for an hour and a half at this point), surgeon decided to use room temperature saline instead of blood - both indicated and viable solutions to use when mixing with the bone cement powder.Surgeon mixed 3cc of bonesync with 2.8cc of saline (2.6cc for faster setting, 2.8cc for facilitated mixing requiring a slightly longer set time).Rep who was present stated the surgeon followed the technique guide steps for mixing and mixed for 35 seconds in the syringe (technique states 30-45 seconds).The solution looked well mixed, homogenous with great consistency.Surgeon attached a 10.5g delivery cannula and injected into the 4 predrilled sites (2 proximal holes and 2 distal holes) within 2 minutes of mixing.Solution delivered very nicely, filling each hole completely and using the back of a tissue elevator to flatten the surface.Surgeon squeezed some of the remaining solution onto the back table as a ¿test¿ subject to observe the hardening process.They waited 6 minutes after injection, and when testing the surface of the solution in the hole, it was still very paste like.The surgeon checked at 10 minutes, same consistency.Surgeon let it sit for 30 minutes and the solution did not harden as anticipated.The solution on the back table became brittle and crumbled, instead of maintaining a hard consistency.The surgeon then attempted to insert an anchor into the proximal lateral hole, but there was a very subtle squeak with the last 2 turns of the anchor, suggesting that there was inadequate fixation as compared to the usual, loud squeaking sound when encountering great fixation into bone, and eventually pulled out.The proximal medial anchor actually had decent bite though.The surgeon attempted to replace the proximal lateral row anchor with a mitek 6.5 metal anchor, but even that pulled out with the very bad quality of bone.Surgeon then attempted to put in distal row anchors.The distal medial anchor stayed with adequate, but subpar fixation.The distal lateral anchor pulled out.Surgeon then increased to a 6.25mm swivelock, and that pulled out.Running out of options, the surgeon decided to fixate the lateral side of the tendon using a bone tunnel in the calcaneus and suture, but even the suture pulled through the bone! sales rep who was present stated there was unbelievably poor bone quality.The sales rep states the surgeon followed the technique step by step from the arthrex website, as the sales rep had read out loud to the doctor and staff.

• Brand Name: BIOCOMP-TENO SWIVELOCK, 6.25 X 15, VE5
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9438176
• Report Number: 1220246-2019-01461
• Device Sequence Number: 3623055
• Product Code: HWC
• UDI-Device Identifier: 00888867233980
• UDI-Public: 00888867233980
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: BIOCOMP-TENO SWIVELOCK, 6.25 X 15, VE5
• Device Catalogue Number: AR-1562CDS
• Device Lot Number: 10221226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/09/2019
• 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