MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,24MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,24MM LGTH
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/11/2018
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 discarded by the facility and will not be returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a revision procedure, during removal of a 3.5mm compression ft screw, the driver tip broke.The surgeon had placed a guide pin in the screw to guide the driver into the screw, so when the driver broke, the broken piece stayed on the guide pin and was easily retrieved from the patient.To complete the screw removal, the surgeon opened up the knee and completed the hardware removal using the non-cannulated t10 hex driver that we also had in the set.Additional information provided 6/26/2018: patient underwent 11 months post-op revision for knee compartment pain, doc was unsure if the screw was causing this issue but the patient's pain persisted.He wanted to see what was going on in the knee and since he was going in, he would remove the screw.Removed an ar-8730-xxh, surgeon believed the size was 24mm in length.Additional information provided 6/27/2018: the original dos was (b)(6) 2017.Screw removed was an ar-8730-24h, lot: 10029598.

• Brand Name: COMPR FT SCRW,3.5 MINI,24MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7642682
• Report Number: 1220246-2018-00531
• Device Sequence Number: 11237511
• Product Code: HWC
• UDI-Device Identifier: 00888867127012
• UDI-Public: 00888867127012
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: No Information
• Device Model Number: COMPR FT SCRW,3.5 MINI,24MM LGTH
• Device Catalogue Number: AR-8730-24H
• Device Lot Number: 10029598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/27/2018
• 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