MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPRESSION SCREW; SCREW, FIXATION, BONE

Catalog Number	AR-5025B-222
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is one of two submissions from the same event, the other one is (b)(4).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.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation of the returned device fragment revealed a broken implant.The implant fragment's fracture surface displayed a torsional fracture pattern indicating that the complainant's event is likely to have been caused by the use of excessive force and/or improper bone preparation prior to insertion.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.
Event or Problem Description
It was reported that during an ocd lesion micro-fracture procedure the surgeon used the k-wire, predrilled and pre-tapped.Halfway through insertion, the implant ar-5025b-24 lot 10042879 ((b)(4)) broke.The screw was removed but fragments remained in the patient.The surgeon tried a second smaller implant ar-5025b-22 lot 10033308 ((b)(4)) and the same issue occurred, leaving fragments in the patient.A third smaller implant ar-5025b-20 lot 1217167 ((b)(4)) was attempted and this one about 1/4 of the way down the threads began to compress and surgeon chose to remove the screw while still whole.The surgeon completed the case with k-wires.Patient was a (b)(6) female.

• Brand Name: BIO-COMPRESSION SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5868146
• Report Number: 1220246-2016-00324
• Device Sequence Number: 1504054
• Product Code: HWC
• UDI-Device Identifier: 00888867034716
• UDI-Public: 00888867034716
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K060478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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: 02/01/2018
• Device Catalogue Number: AR-5025B-222
• Device Lot Number: 10033308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/11/2016
• 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: 20 YR