MAUDE Adverse Event Report: ARTHREX, INC. PEEK TENO SCRW,PEEK,VENT; SCREW, FIXATION, BONE

Model Number	PEEK TENO SCRW,PEEK,VENT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
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 device was reported to have been discarded.The 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 mcl reconstruction, the surgeon tried to insert the peek tenodesis screw, ar-1540ps, but could not get it to engage.A second peek tenodesis screw, ar-1540ps was opened and inserted on the ulnar side.No further details, additional information requested.Additional information provided on 12/28/2018: it was reported that since the surgery was an open procedure, the surgeon did not have to create a portal on the ulnar side.When asked the quality of bone, the response was "not provided." no further details provided.

• Brand Name: PEEK TENO SCRW,PEEK,VENT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8209169
• Report Number: 1220246-2019-00826
• Device Sequence Number: 1656406
• Product Code: HWC
• UDI-Device Identifier: 00888867018747
• UDI-Public: 00888867018747
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 04/30/2023
• Device Model Number: PEEK TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1540PS
• Device Lot Number: 10209941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/02/2019
• 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