LEWIN BONE HOLD CLAMP 7 225175

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-12 for LEWIN BONE HOLD CLAMP 7 225175 manufactured by Integra York, Pa Inc..

Event Text Entries

[90312442] On 9/28/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the instrument has not been returned, the investigation is based on the picture supplied in the parent record. Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable. Engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: there was one picture supplied to us for this investigation. The picture of the lewin bone hold clamp shows wear. The complaint report of broken has been confirmed; we cannot determine the root cause without the instrument being returned for our investigation.
Patient Sequence No: 1, Text Type: N, H10


[90312443] Customer initially reported that the surgeon was using the lewin clamp to clamp down on patients bone and the entire tip broke off once clamped. No patient injury. On 9/21/2017 customer reports device broke during a right total hip arthroplasty, piece retrieved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2017-00091
MDR Report Key6946145
Report SourceUSER FACILITY
Date Received2017-10-12
Date of Report2017-09-19
Date of Event2017-08-29
Date Mfgr Received2017-10-17
Device Manufacturer Date2016-07-01
Date Added to Maude2017-10-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEWIN BONE HOLD CLAMP 7
Generic NameN/A
Product CodeGEN
Date Received2017-10-12
Returned To Mfg2017-10-16
Catalog Number225175
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-12

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