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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 4.0MM DRILL GUIDE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH 4.0MM DRILL GUIDE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 2107-4017
Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the product 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.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that a 4.0 drill bit would not pass through oblique angle side of the 4.0 drill guide smoothly.The right angle side was used instead.Procedure completed successfully with no delay and no adverse affects to the patient.Operative site was the patient's right hip.
 
Manufacturer Narrative
An event regarding damage involving a trident guide was reported.The event was confirmed.Device evaluation and results: examination of the returned device with a material analysis engineer indicated damage observed on guide hole, consistent with galling and contact against a hard object.Medical records received and evaluation: not performed as no adverse consequences to the patient were reported.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other event for the lot referenced.Conclusions: the reported event was confirmed.Visual inspection of the returned device shows that the device was damaged.Examination of the returned device with a material analysis engineer indicated damage observed on guide hole, consistent with galling and contact against a hard object.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
 
Event Description
It was reported that a 4.0 drill bit would not pass through oblique angle side of the 4.0 drill guide smoothly.The right angle side was used instead.Procedure completed successfully with no delay and no adverse affects to the patient.Operative site was the patient's right hip.
 
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Brand Name
4.0MM DRILL GUIDE
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6855949
MDR Text Key85744397
Report Number0002249697-2017-02725
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/28/2017
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 Number2107-4017
Device Lot Number28089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2017
Initial Date FDA Received09/11/2017
Supplement Dates Manufacturer Received10/30/2017
Supplement Dates FDA Received11/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2016
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;
Patient Age61 YR
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