MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C, 5.5X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK SWIVELOCK C, 5.5X19.1MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2019
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 during an arthroscopic rotator cuff repair right shoulder procedure, the tip of the ar-2323pslc suture anchor peek swivelock broke off in the bone.Decision was made by surgeon to leave the broken tip in the patient.The remaining parts of the anchor were sent to the facility's risk management.The facility reported the remaining portions are available to return for evaluation.The original intended procedure was as follows; arthroscopic rotator cuff repair right shoulder.Arthroscopic extensive debridement of the glenohumeral joint including articular.Cartilage, labrum, para-labral cyst, subacromial scarring and adhesions, intra-articular biceps tendon.Open excisional biopsy lateral soft tissue lesion right shoulder.
Event or Problem Description
Additional information received on 01/10/2020: the facility reported there were no attempts made to remove the broken tip, and it was left in the bone.No extra incisions were made, and the case was completed by using another manufacturer's anchors.The bone was medium density.A swivellock punch was used to prepare the bone.The remaining portion of the complaint device will be returning for evaluation.There was not an arthrex sales representative present during the case.
Additional Manufacturer Narrative
Complaint confirmed, the anchor was found to be broken.Likely causes include improper bone prep, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: PEEK SWIVELOCK C, 5.5X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506179
• Report Number: 1220246-2019-01516
• Device Sequence Number: 19296157
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: 00888867026797
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 08/31/2024
• Device Model Number: PEEK SWIVELOCK C, 5.5X19.1MM
• Device Catalogue Number: AR-2323PSLC
• Device Lot Number: 10372821
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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
• Patient Weight: 98