OFFSET DOUBLE CLAMP BAR 00-1238-004-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-06-12 for OFFSET DOUBLE CLAMP BAR 00-1238-004-00 manufactured by Zimmer Orthopaedic Surgical Products.

Event Text Entries

[1137317] A 31" offset double clamp bar was returned to the mfr. Visual inspection revealed a broken clamp. There was no report of injury or medical intervention associated with this incident.
Patient Sequence No: 1, Text Type: D, B5


[8475764] Visual inspection of the returned device confirmed that the clamp was broken. This mdr is being submitted late, as it was identified as part of a retrospective review conducted by zimmer orthopedic surgical products (zimmer osp). This retrospective review was conducted in response to an inspectional observation at a zimmer facility. The agency's inspectional observation concerned the company's decision(s) not to submit certain mdrs for products specific to that zimmer facility. While a retrospective review of complaints for unreported mdrs was conducted immediately following the inspection at the facility, zimmer determined that such a review would be conducted at all zimmer facilities. As a result, zimmer osp completed its retrospective review and is now submitting this mdr.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1035617-2009-00029
MDR Report Key1475801
Report Source05,07
Date Received2009-06-12
Date of Report2007-08-08
Date of Event2007-08-01
Date Mfgr Received2007-02-01
Date Added to Maude2010-03-19
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 FDA0
Event Location0
Manufacturer ContactJOHN WATKINS
Manufacturer Street200 W. OHIO AVE.
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal44622
Manufacturer Phone3303649483
Manufacturer G1ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
Manufacturer Street2021 OLD MOUNTAIN RD.
Manufacturer CitySTATESVILLE NC 28677
Manufacturer CountryUS
Manufacturer Postal Code28677
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOFFSET DOUBLE CLAMP BAR
Generic NameOFFSET DOUBLE CLAMP BAR
Product CodeILZ
Date Received2009-06-12
Returned To Mfg2007-08-28
Model NumberNA
Catalog Number00-1238-004-00
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
Manufacturer Address2021 OLD MOUNTAIN RD. STATESVILLE NC 28677 US 28677


Patients

Patient NumberTreatmentOutcomeDate
10 2009-06-12

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