MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TUBULAR CHISEL 8.5MM AMP; ARTHROSCOPE

Model Number	7205494
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.An analysis of the customer provided images confirmed the device type, part number, and batch number.The device appears used, but not worn.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during rotator cuff procedure outside the patient, the tubular chisel 8.5mm was broken.Backup device was available to complete the procedure.No significant delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: TUBULAR CHISEL 8.5MM AMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11649294
• Report Number: 1219602-2021-00421
• Device Sequence Number: 3367413
• Product Code: HRX
• UDI-Device Identifier: 03596010252357
• UDI-Public: 03596010252357
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K964215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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 Model Number: 7205494
• Device Catalogue Number: 7205494
• Device Lot Number: 50646877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1