MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number 71360093

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Event Description

It was reported that during procedure the black impactor done broke.No injuries or delays reported.Backup device available.No more information provided yet.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A section of the plastic impactor tip on the device fractured off and was not returned.The tip also had numerous nicks in the surface.The device was manufactured in 2013 and exhibits signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.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.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that it is unknown if this device broke above the incision, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: 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: 8928789
• MDR Text Key: 155534281
• Report Number: 1020279-2019-03154
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010619310
• UDI-Public: 03596010619310
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71360093
• Device Lot Number: 13DM00446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1