MAUDE Adverse Event Report: ARTHREX, INC. BASEPLATE IMPACTOR, BASEPLATE ADAPTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BASEPLATE IMPACTOR, BASEPLATE ADAPTOR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/07/2021 it was reported by a sales representative via sems that.The below instruments were damaged in a hardware removal case on (b)(6) 2021: ar-9545-t15-01, ar-9545-t15-02, ar-9545-t15-03, ar-9165adg.Additional information 12/07/2021: on 12/07/2021, it was reported by a sale representative via email that ar-9165adg( line # 1).
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, the circular tabs were found to be broken.No additional damage observed.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: BASEPLATE IMPACTOR, BASEPLATE ADAPTOR
• 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: 13087696
• Report Number: 1220246-2021-04171
• Device Sequence Number: 17570573
• Product Code: LXH
• UDI-Device Identifier: 00888867239395
• UDI-Public: 00888867239395
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: BASEPLATE IMPACTOR, BASEPLATE ADAPTOR
• Device Catalogue Number: AR-9165ADG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 12/29/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown