MAUDE Adverse Event Report: ARTHREX, INC. PEEK, SWIVELOCK FT, 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK, SWIVELOCK FT, 4.75X19.1MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
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
Rotator cuff repair- surgeon had punched a hole in the humerus.He then went to insert a ar-2324pct into the hole.The hole was at a reasonably steep angle to the insertion angle of the swivelock.He inserted the eyelet into the hole.Then the eyelet broke off.The swivelock inserter construct was removed from the shoulder.The eyelet remained attached to the fibertape.All pieces of the eyelet appear to be present.It was noted that the swivelock anchor itself was not on the insertor construct when it was returned to the scrub table.Surgeon notified by rep.Surgeon searched shoulder arthroscopically at end of case and palpated shoulder.Swivelock not found.Surgeon unconcerned, believed it may have been lost on the or floor.Rep believes that the swivelock was not faulty, but that the eyelet breakage was likely due to levering force on swivelock inserter construct with the eyelet in the hole.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the broken eyelet.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 12770772
• Report Number: 1220246-2021-03910
• Device Sequence Number: 4949440
• Product Code: MAI
• UDI-Device Identifier: 00888867098107
• UDI-Public: 00888867098107
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Model Number: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown