MAUDE Adverse Event Report: ARTHREX, INC. GRSPR, MINI, 2.75 STR SR HDL W/FLUSHPORT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	GRSPR, MINI, 2.75 STR SR HDL W/FLUSHPORT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During evaluation of the device it was found that the jaw is broken off.A customer update was then received which stated that the device broke off during surgery and that no further information is available.There was no harm for patient, operator or third party reported by the customer.
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 upper jaw of the device was missing.The broken piece was not returned for investigation.The cause of this remains undetermined, however probable cause can be attributed to the application of prying/leveraging forces.

• Brand Name: GRSPR, MINI, 2.75 STR SR HDL W/FLUSHPORT
• 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: 15250090
• Report Number: 1220246-2022-05407
• Device Sequence Number: 5807783
• Product Code: MDM
• UDI-Device Identifier: 00888867252462
• UDI-Public: 00888867252462
• 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): 12/05/2022

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: GRSPR, MINI, 2.75 STR SR HDL W/FLUSHPORT
• Device Catalogue Number: AR-11900SRF
• Device Lot Number: 10350623
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown