MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC REV/RT/RT MOD. CHISEL HANDLE; CHISEL, SURGICAL, MANUAL

Model Number	75100390
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the chisel handle broke in half during impaction.All pieces recovered.No surgical delay or injury to the patient was reported.It is unknown if/how the procedure was completed.
Event or Problem Description
It was reported that the chisel handle broke in half during impaction.All pieces recovered.No surgical delay or injury to the patient was reported.The procedure was completed using a chisel from another company.
Additional Manufacturer Narrative
Additional information in d9.Internal complaint reference number: case- (b)(4).Corrected event description in b5.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that smith and nephew is the distributer of this device.The legal manufacturer, mps precimed sa, will review the event and determine reportability, therefore, it was determined that this case does not meet the threshold for reporting by smith and nephew and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: TC REV/RT/RT MOD. CHISEL HANDLE
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11112885
• Report Number: 9613369-2021-00003
• Device Sequence Number: 19097619
• Product Code: FZO
• UDI-Device Identifier: 07611996117790
• UDI-Public: 07611996117790
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100390
• Device Catalogue Number: 75100390
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 12/15/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/14/2021; 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention