MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.5MM HEX, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 8/15/2023, it was reported by a sales representative via sems that an ar-8737-37 driver shaft, 1.5 mm hex, cannulated, had an issue.The driver tip broke in the comp ft screw and would not come out.This was discovered during an unspecified time on (b)(6) 2023.No case/patient involvement.Additional information was requested.On 8/25/2023, the sales representative stated the following information via phone: this occurred during use in a dip fusion procedure.The instrument was not used with power.The broken driver tip was removed from a micro comp ft screw 32mm, but the screw was damaged and could not be inserted fully.It also could not be removed by the surgeon, so it was left inside the patient but was not seated fully flush.There was no deviation from the intended procedure, and the procedure was completed.This caused a two-hour case delay, and additional anesthesia had to be administered to the patient.Additional information was requested.On 8/29/2023, the sales representative provided the following information via email: the lot number for the micro 32mm screw was not available.It could not be confirmed if a second surgery would be needed.
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.
Additional Manufacturer Narrative
Additional information: h6 complaint confirmed.One unpackaged ar-8737-37 batch 1392307 was received for investigation.Upon visual inspection, it was noted that the drill tip was broken off.Scratches were observed on the drill's connector.The most likely cause is attributed to over-torquing/over-engaging the driver with the screw head.

• Brand Name: 1.5MM HEX, CMP FT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17701973
• Report Number: 1220246-2023-07814
• Device Sequence Number: 12449052
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: 00888867127159
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Followup
• Report Date (Section B): 12/27/2023

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: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Device Lot Number: 1392307
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown