MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SLEEVE/ STEM SEPARATOR; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71360919
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handle broke in half when the separator was used and impacted with a mallet.No injury reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned sleeve/ stem separator indicated that the handle fractured into two pieces.Both portions were returned.This device was manufactured in 2012, showing signs of wear from use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The supply quality was made aware of the complaint.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: SLEEVE/ STEM SEPARATOR
• Common Device Name: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8704299
• Report Number: 1020279-2019-02301
• Device Sequence Number: 19355758
• Product Code: MEH
• UDI-Device Identifier: 03596010535245
• UDI-Public: 03596010535245
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113789
• 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): 07/13/2019

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: 71360919
• Device Lot Number: 12FSY0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1