MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 20° FULL AUGMENT SIZER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	24MM BASEPLATE, 20° FULL AUGMENT SIZER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/14/2022, it was reported by a sales representative via sems that an ar-9625 3.0mm hex driver and an ar-9592-2420 24mm baseplate had an issue, both items broke while being used.They were recovered and discarded.This was discovered during use on (b)(6) 2022 with no impact to the patient.Additional information was requested.On 06/15/2022, the sales representative replied via email and stated the following information: this event occurred on (b)(6) 2022 during a reverse total shoulder procedure.The sales representative present at the case was bryson eldridge, the bone quality of the patient was not provided, and no instrument was used to prepare the bone socket for the insertion of the implants.The case was completed with different instrumentation and the patient is fine to date.
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.

• Brand Name: 24MM BASEPLATE, 20° FULL AUGMENT SIZER
• 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: 14914682
• Report Number: 1220246-2022-05165
• Device Sequence Number: 19330290
• Product Code: LXH
• UDI-Device Identifier: 00888867343719
• UDI-Public: 00888867343719
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 07/05/2022

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: 24MM BASEPLATE, 20° FULL AUGMENT SIZER
• Device Catalogue Number: AR-9592-2420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown