MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE; PIN, FIXATION, SMOOTH

Model Number	DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2020
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 that the patient had a hammertoe correction procedure.Six weeks post op it was discovered that the implant device broke.The patient is a 76 year old female.At time of initial report the specific arthrex part number was unknown and surgeon does not have immediate plans to remove the device.Additional information obtained 12/24/2020; sales rep called with part number ar-4159-11d.Additional information obtained 1/5/2021: the patient has confirmed that the end of the ar-4159-11d that extrudes from the end of the toe was able to be pulled out by the surgeon in his clinic.This portion of the wire will be returned to arthrex for evaluation.The remaining portion of the wire was left in the patient with no plans to explant it unless it causes the patient discomfort in the future.Patient states the wire being broken does not allow for a fully successful hammertoe correction.Additional timeline information obtained from patient's surgeon 1/11/2021: (b)(6) 2020: left opening wedge proximal first metatarsal osteotomy, modified akin procedure, second hammertoe correction with metatarsophalangeal joint capsulotomy and extensor tendon lengthening.Second hammertoe was corrected with a nitinol k wire placed across the mtp joint in about 10 degrees of plantarflexion.(b)(6) 2020: patient presents for first postop visit.She¿s been non-weight bearing.Patient given cam boot and allowed to weight bear.She ends up staying mostly non-weight bearing still.X-rays show no wire failure.(b)(6) 2020: sutures removed in clinic.(b)(6) 2020: 6 week follow up.¿she is doing well.She has noticed that her second mtp joint is hyperextending again.She says that she did have 1 small stumble and has been pretty gentle on her foot, barely ever weight bearing.She denies any complications otherwise.¿ x-rays show pin has broken.Thankfully the proximal wire is deep to the second metatarsal head and sub-chondral surface.Distal wire removed.Patient instructed to range toe to prevent hyperextension.If grinding is noted, she is to come in for repeat x-rays to ensure pin is not protruding into joint.(b)(6) 2020: patient follows up prior to going out of town.No new grinding.Working on range of motion to joint.Patient to follow up in another 6 weeks.

• Brand Name: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11147047
• Report Number: 1220246-2021-02463
• Device Sequence Number: 19002009
• Product Code: HTY
• UDI-Device Identifier: 00888867334892
• UDI-Public: 00888867334892
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K200068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Device Catalogue Number: AR-4159-11D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/11/2021
• 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
• Patient Age: 76 YR