MAUDE Adverse Event Report: ARTHREX INC. IMPLANT DELIVERY SYSTEM, DISTAL BICEPS REPAIR; PLATE, FIXATION, BONE

Catalog Number AR-2260

Device Problems Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2017

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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.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 reported that during a distal biceps repair procedure, after the surgeon inserted the inserter through the cortices, instead if pushing the button, he yanked the device and the tip of the inserter-broke off and was unable to be retrieved.A post-op x-ray was taken and the broken tip of the device was visible.The button was fully seated and the case was completed as expected.Patient is a male, (b)(6).

• Brand Name: IMPLANT DELIVERY SYSTEM, DISTAL BICEPS REPAIR
• Type of Device: PLATE, FIXATION, BONE
• 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: 7137336
• MDR Text Key: 95452542
• Report Number: 1220246-2017-00489
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/21/2017

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: 01/01/2022
• Device Catalogue Number: AR-2260
• Device Lot Number: 10113055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/21/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 82