MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM; SCREW, FIXATION, BONE

Model Number	SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2021
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
On (b)(6) 2021, it was reported by a sales representative via email that (2) ar-1927psf-475 peek corkscrew broke.This was discovered during a procedure on (b)(6) 2021, when surgeon punched in preparation for implant, both suture anchor peek corkscrew broke during insertion.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1927psf-475 was received for investigation.Visual inspection identified that the peek implant broke into two fragments, starting at the fourth distal-most thread.The eyelet was not returned for analysis, although the suture present at the distal tip was noted to be frayed.The cause remains undetermined.It was noted that the method used to prepare the bone during the procedure, as well as the bone quality encountered, were not recorded.As such, a probable cause can be attributed to improper bone preparation.

• Brand Name: SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12696960
• Report Number: 1220246-2021-03840
• Device Sequence Number: 11951329
• Product Code: HWC
• UDI-Device Identifier: 00888867238602
• UDI-Public: 00888867238602
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927PSF-475
• Device Lot Number: 10164752A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown