MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN BAY PT 1.3X140; PLATE, FIXATION, BONE

Catalog Number	128039
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a malfunction in which there was a delay longer than thirty minutes and the wire became caught in the drill bit and pulled out and was lodged in the drill.No serious injury to the patient reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual examination of the returned guide pin indicated that it is lodged in a drill bit.A review of complaint history did not reveal additional complaints for the listed part.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GUIDE PIN BAY PT 1.3X140
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7751398
• Report Number: 1020279-2018-01469
• Device Sequence Number: 1263486
• Product Code: HRS
• UDI-Device Identifier: 03596010082480
• UDI-Public: 03596010082480
• 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): 08/06/2018

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: 128039
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1