MAUDE Adverse Event Report: ARTHREX, INC. VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-9260-38 volkmann bone hook tip broke.This was discovered during an unspecified time.
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
The complaint is confirmed.One unpackaged ar-9260-38 was received for evaluation.Visual inspection identified the tip of the device had broken.Without additional information, the cause remains undetermined.A probable cause could be attributed to impacting the device against a hard surface, such as bone, or another device.

• Brand Name: VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP
• 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: 15093185
• Report Number: 1220246-2022-05277
• Device Sequence Number: 14466937
• Product Code: LXH
• UDI-Device Identifier: 00888867138414
• UDI-Public: 00888867138414
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/09/2022

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: VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP
• Device Catalogue Number: AR-9260-38
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown