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

Catalog Number	AR-2260
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2017
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.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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7137336
• Report Number: 1220246-2017-00489
• Device Sequence Number: 11030114
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: AR-2260
• Device Lot Number: 10113055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/21/2017
• 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: 60 YR
• Patient Weight: 82