MAUDE Adverse Event Report: STERILMED, INC. CARPAL TUNNEL ECTR BLADE ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MIC81010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a reprocessed carpal tunnel ectr blade assembly and the endoscopic blade broke inside the patient.There was no difficulty, procedural or patient circumstance identified before the break that contributed to the issue reported.The fragments were removed from the patient.No additional intervention was required.However, additional time was needed as there was some difficulty finding the broken pieces inside of the tissue.
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a reprocessed carpal tunnel ectr blade assembly and the endoscopic blade broke inside the patient.We could not confirm the reported issue because the product said to be involved was not received for evaluation and could not be verified as being a sterilmed reprocessed device.Since the device was not returned for evaluation, the visual and functional inspections could not be performed.A manufacturing record evaluation was conducted for the finished device lot 2093460 and no nonconformances were identified.Manufacturer's ref.No: (b)(4).

• Brand Name: CARPAL TUNNEL ECTR BLADE ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 11649205
• Report Number: 2134070-2021-00007
• Device Sequence Number: 11590435
• Product Code: LXH
• UDI-Device Identifier: 10888551001953
• UDI-Public: 10888551001953
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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 Expiration Date: 10/06/2021
• Device Model Number: MIC81010
• Device Catalogue Number: MIC81010
• Device Lot Number: 2093460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1