MAUDE Adverse Event Report: ARTHREX INC. BIO-INTERFERENCE SCREW, FULL THREAD

Catalog Number AR-1380TB

Device Problems Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

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.No device malfunction can be identified.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device was discarded by the facility.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was originally reported that during the surgery the screw broke.Investigation update: one half remained inside the patient the other half was retrieved.The screw does not enter easily into the bone, but the surgeon tried anyway (with force) and so the screw broke on insertion.

• Brand Name: BIO-INTERFERENCE SCREW, FULL THREAD
• Type of Device: BIO-INTERFERENCE SCREW, FULL THREAD
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 6958023
• MDR Text Key: 89613314
• Report Number: 1220246-2017-00378
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867015340
• UDI-Public: 00888867015340
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: AR-1380TB
• Device Lot Number: 10110900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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