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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH CR IMPLANT IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

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SMITH & NEPHEW, INC. ORTHOMATCH CR IMPLANT IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, Back to Search Results
Catalog Number 71436399
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2020
Event Type  malfunction  
Event Description
It was reported that, during an unspecified surgery, the impactor broke down, outside the patient.The fragments of the device did not fall into the patient's body.An s&n backup device was available to complete the procedure with no delay.The patient was not injured: the surgery ended well for him.
 
Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed the orthomatch cr implant impactor is broken into three pieces.The device shows significant signs of 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 products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
ORTHOMATCH CR IMPLANT IMPACTOR
Type of Device
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10047354
MDR Text Key190651579
Report Number1020279-2020-01605
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
PMA/PMN Number
K170648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71436399
Device Lot Number16KSC0018
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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