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

Model Number	EXTERNAL SHEATH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2020
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 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 (b)(6) 2020, during an orif ankle procedure with fibulock nail, the fibulock targeting guides and associated guides were missing the fibulock nail.This resulted in the screw being inserted in the fibula to the left of the nail, but not in the fibulock nail itself, thus compromising the reduction and alignment of the internally fixated fibula.It was reported that (b)(6) 2020, during an orif ankle procedure with fibulock nail, the fibulock targeting guides and associated guides (ar-8973-01, ar-8973-07, ar-8973-08) were missing the fibulock nail.This resulted in the screw being inserted in the fibula to the left of the nail, but not in the fibulock nail itself, thus compromising the reduction and alignment of the internally fixated fibula.These same three devices were also used in a procedure on (b)(6) 2020 (case (b)(4)) having the same issue/result.The devices will be returned for evaluation under case (b)(4) and evaluation will be applied to both incidents/case numbers.
Additional Manufacturer Narrative
Complaint not confirmed.Visual inspection of the device showed no damage to the device.Measurement of the outer diameter (od) and inner diameter (id) of the shaft both measured within the specification tolerance.No problem was found with the device.

• Brand Name: EXTERNAL SHEATH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10390607
• Report Number: 1220246-2020-02018
• Device Sequence Number: 1896506
• Product Code: LXH
• UDI-Device Identifier: 00888867302044
• UDI-Public: 00888867302044
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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 Model Number: EXTERNAL SHEATH
• Device Catalogue Number: AR-8973-07
• Device Lot Number: 1391830
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other