MAUDE Adverse Event Report: ARTHREX, INC. BONE TAP, CANNULATED, 4.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BONE TAP, CANNULATED, 4.5MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The device met all specifications as received.Visual evaluation revealed that the threaded, distal portion of the cannulated bone tap shaft had broken off prior to receipt for investigation.This type of event is most likely caused by not inserting the device co-axial to the pilot hole, prying/leveraging, the use of excessive force, and/or by improper bone preparation.
Event or Problem Description
It was reported that during a 5th metatarsal fx procedure, the surgeon used a 4.5mm cannulated bone tap, ar-8956c-45t to tap the metatarsal.When removing the bone tap, the shaft broke and the threaded portion of the bone tap remained in the intermedullary canal.Additional information received 10/24/2018: no attempts were made to remove the device however, the rep and surgeon discussed ways to get it out.They spoke to the family, but never attempted to remove it.The patient was closed and splinted.

• Brand Name: BONE TAP, CANNULATED, 4.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8074226
• Report Number: 1220246-2018-00745
• Device Sequence Number: 16735197
• Product Code: LXH
• UDI-Device Identifier: 00888867055728
• UDI-Public: 00888867055728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BONE TAP, CANNULATED, 4.5MM
• Device Catalogue Number: AR-8956C-45T
• Device Lot Number: 1391743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other