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

Model Number	BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during shoulder arthroscopy surgery both anchor did break off right away while attaching to the bone and slightly hammering.The broken off pieces have been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-1922bcm-1 devices were received for investigation (no batch numbers provided).It was identified using digital caliper id: 011 that approximately 27.62mm of one of the two returned pushlock inserter shafts was severely bent, with a crack visible along the distal-most thread of the associated biocomposite screw.Neither of the two devices was returned with a metal eyelet component.No damage was noted to the second returned pushlock, although the biocomposite screw associated with this device was missing.It was noted that the method of bone preparation employed during the procedure was not recorded.The observed condition is most likely the result of improper bone preparation or prying/leveraging the device during insertion.

• 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: 12231716
• Report Number: 1220246-2021-03440
• Device Sequence Number: 4991534
• Product Code: MAI
• UDI-Device Identifier: 00888867022904
• UDI-Public: 00888867022904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Device Catalogue Number: AR-1922BCM-1
• Device Lot Number: 10977673
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1