MAUDE Adverse Event Report: ARTHREX, INC. GUIDEWIRE FOR BIO- COMPRESSION SCREW; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	GUIDEWIRE FOR BIO- COMPRESSION SCREW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The returned ar-1249 met as-received specifications.Visual evaluation revealed that the distal tip of the ar-1249 had broken off prior to receipt for investigation.The breakage point was noted to be uneven, consistent with leveraging of the device.This type of event is most likely caused by excessive driver force applied over the guide pin, the driver tip hitting a flex point of the guide pin, prying/leveraging on the guide during use and/or re-using a guide pin from the single-use disposable kit that has been bent from prior use.
Event or Problem Description
It was reported via medwatch report (b)(4), that a (b)(6) female underwent a right knee arthroscopy with debridement and allograft bone patella tendon bone acl reconstruction.During the procedure the tip of the guidewire from the arthrex acl kit broke and became embedded in the distal femur.Specific (b)(6) 2018 date of procedure was not shown on medwatch report received.(b)(6) 2018 has been entered as the procedure date.Additional information will be requested.Additional information obtained 10/30/2018: date of procedure was (b)(6) 2018.Facility has device and has agreed to return for evaluation.Additional information obtained 11/15/2018: sales rep has confirmed that the correct part number for the guidewire is ar-1249 (not ar-5025k as was reported by the facility in the medwatch).This guidewire is from an ar-1987s kit that was opened for the procedure.

• Brand Name: GUIDEWIRE FOR BIO- COMPRESSION SCREW
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8074625
• Report Number: 1220246-2018-00746
• Device Sequence Number: 16709847
• Product Code: MDM
• UDI-Device Identifier: 00888867006164
• UDI-Public: 00888867006164
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: Health Professional
• Device Model Number: GUIDEWIRE FOR BIO- COMPRESSION SCREW
• Device Catalogue Number: AR-1249
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/15/2018
• 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