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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC JTS DISTAL FEMUR CROSS SCREW; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC JTS DISTAL FEMUR CROSS SCREW; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problems Incorrect Measurement (1383); Unintended Compatibility (4047)
Patient Problems No Consequences Or Impact To Patient (2199); Cancer (3262)
Event Date 01/23/2019
Event Type  malfunction  
Manufacturer Narrative
Further investigation is ongoing at this time.The device is not available for return to stanmore.When a full investigation has been carried out a final report will be made available.Device not returned.
 
Event Description
The surgeon reported: "i think it is the cross screw problem, the two 4mm allen keys are too big for it, although it is ok for the k-wire guide and screw guide.Our experienced nurse help us to found that the synthes 7.3 cannulated screw driver can just fit the cross screw, although it is not totally fit, it can hold it and allow me to insert it.".
 
Manufacturer Narrative
Reported event: an event regarding alleged allen key not fitting cross screw involving a jts distal femur was reported.The event was not confirmed.Method and results: product evaluation and results: visual inspection: not performed as no items were returned.Dimensional inspection: not performed as no items were returned.Functional inspection: not performed as no items were returned.Material analysis: not performed as no items were returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 17jan2019 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding allen key not fitting cross screw.There have been no other events.Conclusions: the investigation concluded that an inspection stage was omitted from the custom production process for the cross screw as a trial fit with the allen key was not performed as required by the design drawing.The allen keys were returned and found to be visually, dimensionally and functionally within specification, the cross screw remains implanted and has not been returned for assessment.The surgeon completed the procedure using an alternative instrument and reported a 20 minute delay to the procedure.Nc/capa has been raised to purchase gauges to allow for inspection of the full form of the aperture.The action is due to be implemented by 30 october 2019.Siw will continue to monitor for trends.H3 other text : remains implanted.
 
Event Description
The surgeon reported: "i think it is the cross screw problem, the two 4mm allen keys are too big for it, although it is ok for the k-wire guide and screw guide.Our experienced nurse help us to found that the synthes 7.3 cannulated screw driver can just fit the cross screw, although it is not totally fit, it can hold it and allow me to insert it.".
 
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Brand Name
PATIENT SPECIFIC JTS DISTAL FEMUR CROSS SCREW
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB  WD6 3SJ
MDR Report Key8339201
MDR Text Key136144594
Report Number3004105610-2019-00030
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 21644
Was Device Available for Evaluation? No
Date Manufacturer Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
IMALK-4 4MM ALLEN KEY LOT B21642; IMLAK-4 (B21642) 4MM ALLEN KEY; IMLAK-4 (B5673) 4MM ALLEN KEY; IMALK-4 4MM ALLEN KEY LOT B21642
Patient Age16 YR
Patient Weight45
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