MAUDE Adverse Event Report: ARTHREX, INC. SCREW SHEATH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCREW SHEATH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/12/2021, it was reported by a sales representative via phone that when the surgeon was inserting the 3.5 locking screw in the proximal shaft of the tibia, the 0643-000 screw sheath locked and the tip sheared off during final fixation of the locking screw.The surgeon was able to back out the locking screw and used fluoroscopy in order to remove all fragments of the 0643-000 from the patient.This was during a pilon fracture on (b)(6) 2021.The case was completed by using a new guide and used the same locking screw.
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.

• Brand Name: SCREW SHEATH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12737765
• Report Number: 1220246-2021-03863
• Device Sequence Number: 4081142
• Product Code: LXH
• UDI-Device Identifier: 00848665027365
• UDI-Public: 00848665027365
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 11/02/2021

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 Model Number: SCREW SHEATH
• Device Catalogue Number: 0643-000
• Device Lot Number: 200587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown