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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 7030-6525
Device Problems Material Discolored (1170); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
 
Event Description
Primary tha.It was reported that after opening the outer sterile blister, the corner of the inner sterile packet was discolored.The device was refused before it entered the sterile field and another screw (different lot) was opened and used to complete the procedure successfully with no delay.
 
Event Description
Primary tha.It was reported that after opening the outer sterile blister, the corner of the inner sterile packet was discolored.The device was refused before it entered the sterile field and another screw (different lot) was opened and used to complete the procedure successfully with no delay.Rep retained all packaging, provided the usage sheet (which does not show the wasted screw), confirmed he was present for and witnessed the procedure, and confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding packaging issue involving a other hip screw was reported.The event was confirmed via product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device was returned new still inside the packaging.The outer blister is observed to be open and a corner of the inner sterile blister around the seal flange was discolored confirming the reported packaging issue event.Clinician review: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device noted the following: device was returned new still inside the packaging.The outer blister is observed to be open and a corner of the inner sterile blister around the seal flange was discolored confirming the reported packaging issue event.Nc was initiated to evaluate the root cause of the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
6.5MM LOW PROFILE HEX SCREW 25MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10861066
MDR Text Key216874535
Report Number0002249697-2020-02490
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327345001
UDI-Public07613327345001
Combination Product (y/n)N
PMA/PMN Number
K161569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/19/2021
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 Model Number7030-6525
Device Catalogue Number7030-6525
Device Lot Number4DYD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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