MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE PIP - STR 14MM - W/INSTR; PIN, FIXATION, SMOOTH

Model Number	DYNANITE PIP - STR 14MM - W/INSTR
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/27/2020
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported the during a left foot hammertoe 2nd metatarsal procedure the hammertoe implant was implanted per the technique.Upon advancing the k-wire to deploy the wings, the k-wire snapped while it was crossing the midpoint of the implant.Wire was advanced on forward, not on oscillate.The implant itself was good, only the k-wire broke.A piece of the guidewire was left in the patient's toe.Part/lot involved: ar-4158ds-14s / lot 10448924.Patient bone quality was normal per the surgeon.

• Brand Name: DYNANITE PIP - STR 14MM - W/INSTR
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10184287
• Report Number: 1220246-2020-01914
• Device Sequence Number: 2729595
• Product Code: HTY
• UDI-Device Identifier: 00888867310018
• UDI-Public: 00888867310018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190287
• 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): 06/23/2020

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: 10/31/2024
• Device Model Number: DYNANITE PIP - STR 14MM - W/INSTR
• Device Catalogue Number: AR-4158DS-14S
• Device Lot Number: 10448924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/23/2020
• 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