MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM INSERTER FRAME; PROSTHESIS,HIP,SEMICONSTRAINED,METAL/POLYMER,CEMENT

Catalog Number	71364008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure modes.The threads fractured off the impactor rod and were not returned.The anti-rotation tabs fractured off the inserter frame and were returned.The devices were manufactured in 2004 and 2006 and exhibit signs of extensive wear / usage.The medical investigation concluded that it was communicated that the threaded tip of the impactor was left inside the hip stem, therefore micro motion and / or migration of the retained stem impactor rod tip is not likely.Based on the product evaluation, the root cause for the instrument failure was due to age related wear.No further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batches.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.
Event or Problem Description
It was reported that during surgery, while impacting, the tip of the device broke.Pieces remain on the patient.Delay from fifteen minutes reported.No backup device was required.No impact or injury to patient reported.

• Brand Name: STEM INSERTER FRAME
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METAL/POLYMER,CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9088147
• Report Number: 1020279-2019-03437
• Device Sequence Number: 2425249
• Product Code: JDI
• UDI-Device Identifier: 03596010199249
• UDI-Public: 03596010199249
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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 Expiration Date: 03/29/2014
• Device Catalogue Number: 71364008
• Device Lot Number: 04BM00991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1