MAUDE Adverse Event Report: ARTHREX, INC. PINLOCK I SCRWDRV 3.5MM HEX 5.5MMX 14CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PINLOCK I SCRWDRV 3.5MM HEX 5.5MMX 14CM
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
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
On 11/11/2022, it was reported by a sales representative via sems that a ar-1399 cannulated screwdriver is broken.This occurred during a case when the device broke.There was no patient effect reported.
Additional Manufacturer Narrative
The complaint was confirmed.Picture evaluation of an ar-1399 pinlock i cannulated screwdriver, 3.5 mm hex, ø 5.5 mm x 14 cm long.Attached to the complaint.It is concluded that the instrument tip was broken/bend.It was also noted signs of wear and tear in the handle.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: PINLOCK I SCRWDRV 3.5MM HEX 5.5MMX 14CM
• 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: 15904176
• Report Number: 1220246-2022-05829
• Device Sequence Number: 5126432
• Product Code: LXH
• UDI-Device Identifier: 00888867015890
• UDI-Public: 00888867015890
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/18/2023

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: PINLOCK I SCRWDRV 3.5MM HEX 5.5MMX 14CM
• Device Catalogue Number: AR-1399
• Device Lot Number: 8001817
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown