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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PRSTHSS, IP, SEMI-CONSTRAINED, METAL/PLYMR,NON-PRS, CLICM-PHSPHT
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SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PRSTHSS, IP, SEMI-CONSTRAINED, METAL/PLYMR,NON-PRS, CLICM-PHSPHT Back to Search Results
Model Number 71360093
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2020
Event Type  malfunction  
Event Description
It was reported that during the tip on the femoral head/neck impactor broke while impacting the femoral head on the stem.It broke over the patient.All broken pieces of the femoral head/neck impactor were recovered from the patient.It is not known if smith & nephew back up was available.No supplemental information is currently available.
 
Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic bumper of the device fractured into multiple pieces, rendering the device inoperable.Not all pieces were returned.The device was manufactured in 2016 and shows 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic bumper of the device fractured into multiple pieces, rendering the device inoperable.Not all pieces were returned.The device was manufactured in 2016 and shows 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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.
 
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Brand Name
FEMORAL HEAD/NECK IMPACTOR
Type of Device
PRSTHSS, IP, SEMI-CONSTRAINED, METAL/PLYMR,NON-PRS, CLICM-PHSPHT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9576120
MDR Text Key177241027
Report Number1020279-2020-00185
Device Sequence Number1
Product Code MEH
UDI-Device Identifier03596010619310
UDI-Public03596010619310
Combination Product (y/n)N
PMA/PMN Number
K113789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number71360093
Device Catalogue Number71360093
Device Lot Number16CM21068
Date Manufacturer Received01/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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