MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1922BCM-1
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2016
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.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.Evaluation revealed the tips were bound on the three drivers used in the case.Thread dimensions were verified to be within specification.Examination under magnification of the threaded interface revealed no anomalies that could have contributed to this event.It was determined they were within normal range of break-away torque.The eyelet was reattached to the driver after examination and there was no evidence of burrs or interference.No other contributing factors could be identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.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 originally reported that the thread was blocked and the implant/tip can`t be turned.No adverse condition reported.Follow-up investigation: the open rotator cuff surgery was finished successfully by switching to a trans-osseous joint technique.Surgery took 15 minutes longer.Patient have no impairments and he is doing well.

• Brand Name: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6105388
• Report Number: 1220246-2016-00496
• Device Sequence Number: 671888
• Product Code: MAI
• UDI-Device Identifier: 00888867022904
• UDI-Public: 00888867022904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: 11/01/2017
• Device Catalogue Number: AR-1922BCM-1
• Device Lot Number: 10019980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• 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