MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL HANDLE; PLATE, FIXATION, BONE

Catalog Number	71177203
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that universal handle did not hold onto multi-parallel pin guide.Therefore, surgeon had to use without handle.Surgeon had to divert from the original procedure to complete the surgery and there was a delay reported of less than 30 minutes.Patient was not affected, surgery finished fine and patient did well intra-operatively.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned universal handle indicated damage to the ball plunger and along the body of the device.This device was manufactured in 2008, showing signs of wear/use.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 part revealed no prior complaints for the listed batch.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: UNIVERSAL HANDLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8184502
• Report Number: 1020279-2018-02852
• Device Sequence Number: 16570588
• Product Code: HRS
• UDI-Device Identifier: 03596010601612
• UDI-Public: 03596010601612
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/11/2019

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: 71177203
• Device Lot Number: 08BM05255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1