MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM EXTRACTOR UNIVERSAL JOINT; PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTL/PLYMR,NN-PRS,CLICUM-PHSPHTE

Catalog Number	71355107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the extractor broke at the threads.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the stem extractor universal joint indicated the threaded male end is stripped, confirming the stated failure.The device was manufactured in 2013.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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 as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: STEM EXTRACTOR UNIVERSAL JOINT
• Common Device Name: PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTL/PLYMR,NN-PRS,CLICUM-PHSPHTE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7806950
• Report Number: 1020279-2018-01601
• Device Sequence Number: 1536319
• Product Code: MEH
• UDI-Device Identifier: 00885556223697
• UDI-Public: 00885556223697
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121627
• 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): 08/22/2018

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: 71355107
• Device Lot Number: 13LPG0030
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/22/2018
• 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
• Outcome Attributed to Adverse Event: Other