MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SURGICAL INC.; RONGEUR

Model Number	57-0763
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the evaluation.
Event or Problem Description
Received via voluntary mw5153291 " kerrison rongeur broke while in use, a pin that holds together multiple pieces came out.All pieces retrieved.
Additional Manufacturer Narrative
Received via voluntary mw5153291.The customer provided a picture which confirmed that the screw to the sliding shaft had fallen out of the device.The device was returned and evaluated.The device was confirmed to have significant wear and tear.We were able to confirm that the lot number is not visible on the device.Based on the appearance of the device the device has significant wear and tear.The customer order history was reviewed, the only purchase for this product code was in (b)(6) 2017.As a result, it is likely that the device had been in use for approximately 7 years prior to the issue occurring.Root cause: wear and tear over many years of use.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
Received via voluntary mw5153291 " kerrison rongeur broke while in use, a pin that holds together multiple pieces came out.All pieces retrieved.

• Brand Name: SYMMETRY SURGICAL INC.
• Common Device Name: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch 37013
• MDR Report Key: 19274311
• Report Number: 3007208013-2024-00017
• Device Sequence Number: 18057174
• Product Code: HTX
• UDI-Device Identifier: 00887482093313
• UDI-Public: 00887482093313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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
• Device Model Number: 57-0763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown