MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD, 52MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,4.0 STD, 52MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
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.Retrieved device piece 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 the surgeon wanted to use a 52mm compression screw, ar-8740-52h, during a 1st tmt fusion for a lisfranc injury.The 3.2 mm long drill from the compression ft tray was used to prep the bone first; then followed by the profile drill for the 4.0 compression ft screws.The surgeon drilled the length of the guide-wire that was inserted.He started the screw on power, and attempted to finish with the hand screw driver.After about 4 turns, he explained he wasn't feeling it advance any further.He checked under flouro and it looked as if the screw had broken.The screw was sitting just a hair proud of the cortex as they were not able to advance the screw any further.He was able to back out the head of the screw portion that was broken off; the screw broke 12mm distal to the head of the screw.The surgeon checked multiple views under live flouro to make sure the part of the screw that was inserted was secure and showed no movement.Additional information provided 10/17/19- the case was completed due to the fact that the screw broke just at the dorsal cortex so it was not too proud.There was not any injury to the patient at the time of closure.The 12mm fragment will not be returned as it was discarded after the case since it had been in the patient.The surgeon is concerned the patient may require a second surgery to remove the screw if it becomes painful.As of right now though, there is no need for a second surgery.

• Brand Name: COMPR FT SCRW,4.0 STD, 52MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9287214
• Report Number: 1220246-2019-01397
• Device Sequence Number: 16670475
• Product Code: HWC
• UDI-Device Identifier: 00888867303416
• UDI-Public: 00888867303416
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183261
• 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): 11/06/2019

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 Model Number: COMPR FT SCRW,4.0 STD, 52MM
• Device Catalogue Number: AR-8740-52H
• Device Lot Number: 10282443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/06/2019
• 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