MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, PEEK; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, PEEK
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2018
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 by the facility.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 wrist joint ligament reconstruction procedure, the tip of inserter for the peek tenodesis screw broke off while inserting the screw.The broken tip was lodged i the head of the screw and was not able to be retrieved and is still in the patient.*no further details.
Additional Manufacturer Narrative
Complaint confirmed, evaluation of the device shows that 0.88in of the device extremity is missing.The most likely cause(s) of this type of event include flexing the joint during insertion of the implant with the driver engaged or prying/leveraging the driver while the implant is still loaded.

• Brand Name: TENODESIS SCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7788236
• Report Number: 1220246-2018-00598
• Device Sequence Number: 14065197
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• 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,Followup
• Report Date (Section B): 01/21/2019

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: 09/30/2022
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10168970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 01/21/2019
• 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