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

Model Number	BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	08/02/2021
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 it was not possible to inscrew the implant holder which resulted in a removal of the device.It was not possible to reimplant the device.There was no harm for patient, operator or third party reported.No further information received.On 16-aug-2021: update: further information were provided that the reported event occurred during a surgery and the surgeon had to switch from a double row suture to a single row.On 23-aug-2021: update it was further reported that the reported event occurred during a rotator cuff surgery.On 24-aug-2021: update: further details about the event were provided.During the surgery it was not possible to inscrew the implant holder.Due to this failure the device broke while forcing on the screwdriver.Therefore it was not possible to reimplanting another anchor at this place since a piece of this anchor remained in the patient and the surgery was then finished with a single row suture instead of a double row.On 25-aug-2021: update: further information were provided by the surgeon that the initially provided information was not correct.The implant could not be detached from the metal tip.The surgeon had to pull on the handle to remove the whole device.This resulted in bone damage for the patient and the implant site was enlarged.She was not able to leave it in that location and therefore only able to do a single row.
Additional Manufacturer Narrative
Complaint not confirmed.Visual evaluation did not show any damaged to the returned device.All components are still present and undamaged.Functional evaluation showed the metal tip eyelet was able to be unscrew.Device was functional.

• Brand Name: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• MDR Report Key: 12466915
• Report Number: 1220246-2021-03627
• Device Sequence Number: 3735997
• Product Code: MAI
• UDI-Device Identifier: 00888867022904
• UDI-Public: 00888867022904
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 10/31/2024
• Device Model Number: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Device Catalogue Number: AR-1922BCM-1
• Device Lot Number: 12088997
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other