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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC SM FRAG INST & IMPLANT SET LID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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SMITH & NEPHEW, INC. PERI-LOC SM FRAG INST & IMPLANT SET LID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 71170660
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  malfunction  
Manufacturer Narrative
Case (b)(4).
 
Event Description
It was reported that the device is peeling.Unknown when the incident occurred, of occurred a surgical delay and how the procedure finished.Patient injuries were not reported.
 
Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and 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.
 
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Brand Name
PERI-LOC SM FRAG INST & IMPLANT SET LID
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11204269
MDR Text Key227862680
Report Number1020279-2021-00508
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00885556015933
UDI-Public00885556015933
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71170660
Device Catalogue Number71170660
Device Lot Number10HAV0003
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/30/2020
Patient Sequence Number1
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