MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN SCREWDRIVER 6.5; NAIL, FIXATION, BONE

Catalog Number	110120
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a delay greater that 30 minutes occured due to worn out screwdriver.
Additional Manufacturer Narrative
The associated small slap hammer was not returned for evaluation.Therefore the product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: CANN SCREWDRIVER 6.5
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8084474
• Report Number: 1020279-2018-02539
• Device Sequence Number: 19265916
• Product Code: JDS
• UDI-Device Identifier: 03596010033970
• UDI-Public: 03596010033970
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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 Catalogue Number: 110120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1