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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ADM BALL IMPACTOR TIP; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH ADM BALL IMPACTOR TIP; INSTRUMENT Back to Search Results
Catalog Number 1235-0-013
Device Problems Break (1069); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2015
Event Type  malfunction  
Event Description
It was reported that surgeon preformed a cup revision (competitor) with trident psl and mdm.During surgery, when surgeon was closing, scrub nurse disconnected the adm ball impactor tip (1235-0-013) from the cup impactor (2101-0130).At this time the adm ball impactor tip broke in half.
 
Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
 
Manufacturer Narrative
An event regarding crack/fracture involving an adm impactor was reported.The event was confirmed.Method & results: device evaluation and results: the device has fractured on the threaded side of the device.Medical records received and evaluation: not performed as medical records were not provided or relevant to the event.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: this event is currently under investigation in capa.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that surgeon preformed a cup revision (competitor) with trident psl and mdm.During surgery, when surgeon was closing, scrub nurse disconnected the adm ball impactor tip (1235-0-013) from the cup impactor (2101-0130).At this time the adm ball impactor tip broke in half.
 
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Brand Name
ADM BALL IMPACTOR TIP
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4853925
MDR Text Key5932896
Report Number0002249697-2015-01976
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1235-0-013
Device Lot NumberG3673053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2015
Initial Date FDA Received06/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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