MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN SCREWDRIVER 4.0; PLATE, FIXATION, BONE

Model Number	117070
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection a cann screwdriver 4.0 was stripped.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting 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: CANN SCREWDRIVER 4.0
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11683482
• Report Number: 1020279-2021-03055
• Device Sequence Number: 14233408
• Product Code: HRS
• UDI-Device Identifier: 03596010054838
• UDI-Public: 03596010054838
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 02/21/2010
• Device Model Number: 117070
• Device Catalogue Number: 117070
• Device Lot Number: 00209346
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1