MAUDE Adverse Event Report: ARTHREX, INC. HIP ARTHRSCPY DISP. KIT W/BANANA BLADE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	HIP ARTHRSCPY DISP. KIT W/BANANA BLADE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-6527s banana blade had no edge.During a capsulotomy the doctor made several attempts but it would not cut.To complete the case the surgeon used a scalpel.No patient affect.

• Brand Name: HIP ARTHRSCPY DISP. KIT W/BANANA BLADE
• 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: 14914498
• Report Number: 1220246-2022-05153
• Device Sequence Number: 2033133
• Product Code: MDM
• UDI-Device Identifier: 00888867039902
• UDI-Public: 00888867039902
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: HIP ARTHRSCPY DISP. KIT W/BANANA BLADE
• Device Catalogue Number: AR-6527S
• Device Lot Number: 13987992
• 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
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown