MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISTAL RADIUS DOUBLE PIN DRILL SLEEVE; PLATE, FIXATION, BONE

Catalog Number	71067328
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon states drill sleeve and drill jammed.No delay to procedure, no injury to patient.Device will be returned.Backup used was not from smith and nephew.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual inspection of the returned drill sleeve indicated damage to the inner canal and knurled area.The drill indicated damage around the body of the drill and chuck end, confirming the stated complaint.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: DISTAL RADIUS DOUBLE PIN DRILL SLEEVE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8184055
• Report Number: 1020279-2018-02846
• Device Sequence Number: 19183902
• Product Code: HRS
• UDI-Device Identifier: 03596010607645
• UDI-Public: 03596010607645
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 71067328
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1