MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPS-ITE CRKSCRW 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a (b)(6) 2020 rotator cuff repair (supraspinatus tear) procedure three ar-1927bcf-3, bio-composite corkscrew anchors (lot 11436533), broke on insertion.The top half of the implants broke while anchoring to the humerus.All three anchors wee from the same lot/box.A portion of two of the anchors were pulled from the patient.The distal portions remained in the patient.No new anchors were placed over the existing anchors.One of the anchors that broke on the last few turns of corkscrew and the surgeon left that entire anchor in the patient as it was not proud, but rather flush in the humeral head.No additional or larger incisions were needed and the surgeon did not have to change his planned technique.The surgeon continued on to complete the suture bridge.The portions of anchors that were retrieved were discarded at the time of procedure.The remaining two anchors from the same lot/box will be returned to use for evaluation.
Additional Manufacturer Narrative
It was reported that three anchors broke upon insertion.The reported event is confirmed upon investigation of the returned pictures.Visual evaluation of the provided pictures confirmed that the anchors had broken.Evaluation of the returned corkscrews did not identify any malfunction or abnormality.The reported event was unable to be created with the returned devices.The root cause of the reported failure mode is undetermined.However, the most likely probable causes include improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10746278
• Report Number: 1220246-2020-02259
• Device Sequence Number: 3777369
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 07/31/2024
• Device Model Number: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 11436533
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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