MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SLEEVE/ STEM SEPARATOR; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71360919
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a educational lab, device broke at handle during use.No injury to anyone involved and no delay.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned anthology inserter poster hard indicated the threaded tip fractured off, most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts occurring while the inserter is not fully captured in the driver hole platform of the stem.This fracture caused the instrument to become inoperable.The fractured portion was not returned.A visual inspection of the returned sleeve/ stem separator indicated that the handle fractured into two pieces.The handle end of the fractured portion was not returned.These devices were manufactured in 2017 and 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.No further investigation is warranted for this complaint.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-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8746855
• Report Number: 1020279-2019-02554
• Device Sequence Number: 1707929
• Product Code: LZO
• 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: Other Health Care Professional
• 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: 06/20/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/30/2019
• 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