MAUDE Adverse Event Report: ARTHREX, INC. DRV SFT,T10 HEXALOBE,CANN,STR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRV SFT,T10 HEXALOBE,CANN,STR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a foot surgery the tip broke off inside the patient when turning out the screw.The broken piece was removed from patient.No harm for patient, operator or third party was reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was noted that the tip of the driver was broken off.The broken tip of the device shows twisting.It was also noted that the orange paint groove is chipped/peeling.The cause is undetermined, however a likely cause is over torqueing the device; prying/leveraging the device during use.

• Brand Name: DRV SFT,T10 HEXALOBE,CANN,STR
• 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: 14269993
• Report Number: 1220246-2022-04823
• Device Sequence Number: 17432971
• Product Code: LXH
• UDI-Device Identifier: 00888867046214
• UDI-Public: 00888867046214
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: DRV SFT,T10 HEXALOBE,CANN,STR
• Device Catalogue Number: AR-8737-26
• Device Lot Number: 1391916
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown