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

Model Number DYNANITE PIP - STR 14MM - W/INSTR

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2020

Event Type  Injury  

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 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
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10184287
• MDR Text Key: 196154567
• Report Number: 1220246-2020-01914
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867310018
• UDI-Public: 00888867310018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other