MAUDE Adverse Event Report: ARTHREX, INC. TRANS-FIX II DRILL PIN & GRAFT PASSING WIRE SET; BIT, DRILL

Catalog Number AR-1978S-1

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The complainant's event is typically caused by applying leverage force resulting in improper alignment that is not co-axial with the guide setup.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device requested but not yet received.

Event Description

It was reported that two 40mm transfix pins failed during surgery.On both, head broke off when striking pin into the hole.Surgeon used a 50mm pin instead.Surgery was successfully finished with the new pin.One pin will be returned for evaluation.Update 25-nov-2016: it was reported that a fragment of the pin remained in the bone.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission to reflect device evaluation.Complaint confirmed.The evaluation revealed the implant has sheared in half and cracked at the interface with the impactor.The second piece of the broken implant was not returned for evaluation.The deformed fracture site most likely due to the device being implanted after fracture occurred.The diameter of the device exceeds print specifications; however, this is an expected outcome of the implantation process.The longitudinal crack propagation's asymmetrical shape on the proximal end of the implant is most likely caused by the prepared hole, the implant, and the loading on the implant not being coaxial to one another.Based on the geometry of the fracture, the implant broke at the external edge of the bone, which is consistent with non-axially loading of the implant.The complainant's event is typically caused by not implanting the device coaxially to the prepared hole, prying/leveraging during implantation, or improper bone preparation.

Event Description

It was reported that two 40mm transfix pins failed during surgery.On both, head broke off when striking pin into the hole.Surgeon used a 50mm pin instead.Surgery was successfully finished with the new pin.One pin will be returned for evaluation.Update 25-nov-2016: it was reported that a fragment of the pin remained in the bone.

• Brand Name: TRANS-FIX II DRILL PIN & GRAFT PASSING WIRE SET
• Type of Device: BIT, DRILL
• 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6166145
• MDR Text Key: 62125074
• Report Number: 1220246-2016-00558
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888867025189
• UDI-Public: 00888867025189
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

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 Expiration Date: 09/01/2020
• Device Catalogue Number: AR-1978S-1
• Device Lot Number: 400937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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