MAUDE Adverse Event Report: ARTHREX, INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number REAMER, LOW PROFILE

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, it was reported by a facility representative via sems that ar-1410lp reamer is defectives, not specified; this was discovered during a procedure; no patient was affected.During returned device evaluation, a reportable malfunction was discovered.

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the cutting edges were found to have broken off.No additional damage was observed.The cause of the event is undetermined.

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the cutting edges were found to have broken off.No additional damage was observed.The cause of the event is undetermined.

Event Description

On (b)(6) 2021, it was reported by a facility representative via sems that ar-1410lp reamer is defectives, not specified; this was discovered during a procedure; no patient was affected.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: REAMER, LOW PROFILE
• Type of Device: 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: 13054498
• MDR Text Key: 286062142
• Report Number: 1220246-2021-04142
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867016811
• UDI-Public: 00888867016811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REAMER, LOW PROFILE
• Device Catalogue Number: AR-1410LP
• Device Lot Number: 10328664
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1