MAUDE Adverse Event Report: ARTHREX, INC. SIDE RELEASE RETRO CONSTR HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	SIDE RELEASE RETRO CONSTR HANDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery when the surgeon wanted to use the handle of the viewfinder, he did not succeed in unscrewing the knob.It was blocked, whereas usually, it was easily unscrewed.By forcing to succeed in unscrewing it, the knob ended up breaking.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 27-jun-2022: it was confirmed that a part of the device broke off.
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
Complaint confirmed.Upon visual inspection, it was noted that the holes within the knob used to assemble the dowel, attaching the knob to the device were broken.The dowel was found to still be assembled to the lock pin.It was also noted that the knob shows signs of damage.

• Brand Name: SIDE RELEASE RETRO CONSTR HANDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 15041085
• Report Number: 1220246-2022-05254
• Device Sequence Number: 12511372
• Product Code: MDM
• UDI-Device Identifier: 00888867196773
• UDI-Public: 00888867196773
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/07/2022

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: SIDE RELEASE RETRO CONSTR HANDLE
• Device Catalogue Number: AR-1510HR
• Device Lot Number: 43212103
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown