MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2019
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 requested/is expected but has 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 case, the implants pulled out.Reporter has no further details; additional information requested.Additional information received 3/28/2019: during a modified broström procedure, the surgeon prepped two pilot holes in the patient's soft bone fibula with a 2.4 suturetak drill bit.He inserted a peek suturetak suture anchor and the anchor pulled out.He removed the anchor and opened a second from the same lot and attempted to insert this anchor into the second hole.Again, the anchor pulled out.Unplanned bone tunnels were drilled to finish the procedure vs.Using a different anchor.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8500038
• Report Number: 1220246-2019-01016
• Device Sequence Number: 1884743
• Product Code: HWC
• UDI-Device Identifier: 00888867024120
• UDI-Public: 00888867024120
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 05/31/2023
• Device Model Number: SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
• Device Catalogue Number: AR-1934PF-24
• Device Lot Number: 10216460
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/10/2019
• 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