MAUDE Adverse Event Report: ARTHREX, INC. COMPRESSION FT SCRW,3.5 MINI,26MM LGTH; SCREW, FIXATION, BONE

Catalog Number	AR-8730-26H
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/22/2017
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.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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The device met all material specifications as received.The evaluation revealed that the returned compression screw is broken at the distal tip.The fracture surface displays evidence of torsional-overload.The most likely cause is the bone being improperly prepared, thus creating a situation in which over-torquing could occur.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 the surgeon implanted 3 screws in (b)(6) 2016.On (b)(6) 2017 they wanted to remove the screws.One screw was removed (ar-8730-26h), one screw (ar-8730-34h) was not removed and one screw broke into 2 pieces.The part of the broken screw has not been removed and remains in the patient.The surgeon performed the mtp1 arthrodesis technique.Follow-up investigation: the surgery on (b)(6) 2017 was a pre-planned metal removal surgery.According to the surgeon he wanted to remove all 3 screws and now 1 complete screw and 1 broken screw will remain inside the patient.The surgeon made his own choice to leave the 3rd screw (ar-8730-34h) inside the patient.There are no consequential damages for the patient.Follow-up investigation: our qc was measuring the screw to know which one is the broken on.The broken screw is ar-8730-26h.

• Brand Name: COMPRESSION FT SCRW,3.5 MINI,26MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6724207
• Report Number: 1220246-2017-00262
• Device Sequence Number: 13624497
• Product Code: HWC
• UDI-Device Identifier: 00888867127029
• UDI-Public: 00888867127029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: AR-8730-26H
• Device Lot Number: 1270067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-8730-28H, COMPRESSION SCREW FT, LOT 1270068.
• Outcome Attributed to Adverse Event: Other