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

Catalog Number	71355107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision surgery after removing the redapt stem extractor, the surgeon noticed that this part had cracked from the extraction process.No delay or patient injury reported.The rep stated that all pieces were recovered.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic bushing on the device is cracked.The top of the bushing, above the fracture site, is also damaged.The device was manufactured in 2013 and exhibits signs of extensive wear/ usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.

• Brand Name: STEM EXTRACTOR UNIVERSAL JOINT
• 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: 8475264
• Report Number: 1020279-2019-01324
• Device Sequence Number: 11222614
• Product Code: MEH
• UDI-Device Identifier: 00885556223697
• UDI-Public: 00885556223697
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

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: 71355107
• Device Lot Number: 13APG0022
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 06/20/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/23/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1