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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T7, 2.7X24MM; PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW, T7, 2.7X24MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 53-27624S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Skin Inflammation/ Irritation (4545); Implant Pain (4561)
Event Date 06/20/2022
Event Type  Injury  
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted.
 
Event Description
In 2018, the claimant had an orif and was implanted with unknown pins and a plate, around december 2021/january 2022, she felt some discomfort/irritation and sought medical care.The revision was scheduled for june 2022 to remove the implanted devices.During the surgery, the surgeon discovered that he did not have the correct instruments to remove the hardware.The hospital spent some time trying to find a suitable to assist in the removal, but could not locate a suitable screwdriver.However, one screw was able to be removed through careful use of a smaller screwdriver head.Since the failed surgery, the patient has been left with a raised red rash on her wrist, and is in more pain than before the failed surgery.Additionally, this is affecting her wrist movement more that before the surgery.
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Despite the lack of information on the device, based on the event description, it is highly probable that the device used is part of the variax distal radius brand.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, it was indicated in the event description that the absence of the correct instruments was discovered during the surgery.This gives evidence that hcp failed to properly follow the pre-operative instructions.As a reminder, the instructions for use advise: "¿ ensure that all components needed for the operation are available in the operation theatre." a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
In 2018, the claimant had an orif and was implanted with unknown pins and a plate, around (b)(6)2021/(b)(6)2022, she felt some discomfort/irritation and sought medical care.The revision was scheduled for (b)(6)2022 to remove the implanted devices.During the surgery, the surgeon discovered that he did not have the correct instruments to remove the hardware.The hospital spent some time trying to find a suitable to assist in the removal, but could not locate a suitable screwdriver.However, one screw was able to be removed through careful use of a smaller screwdriver head.Since the failed surgery, the patient has been left with a raised red rash on her wrist, and is in more pain than before the failed surgery.Additionally, this is affecting her wrist movement more that before the surgery.
 
Manufacturer Narrative
Please note the corrections to d1, d4 catalog #, d4 lot #, g1: manufacturing site and h6 method codes.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, it was indicated in the event description that the absence of the correct instruments was discovered during the surgery.This gives evidence that hcp failed to properly follow the pre-operative instructions.As a reminder, the instructions for use advise: "¿ ensure that all components needed for the operation are available in the operation theatre." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
In 2018, the claimant had an orif and was implanted with unknown pins and a plate, around (b)(6) 2021/(b)(6) 2022, she felt some discomfort/irritation and sought medical care.The revision was scheduled for (b)(6) 2022 to remove the implanted devices.During the surgery, the surgeon discovered that he did not have the correct instruments to remove the hardware.The hospital spent some time trying to find a suitable to assist in the removal, but could not locate a suitable screwdriver.However, one screw was able to be removed through careful use of a smaller screwdriver head.Since the failed surgery, the patient has been left with a raised red rash on her wrist, and is in more pain than before the failed surgery.Additionally, this is affecting her wrist movement more that before the surgery.
 
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Brand Name
LOCKING SCREW, T7, 2.7X24MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
postfach
freiburg D-791 11
GM   D-79111
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key16930702
MDR Text Key315204556
Report Number0008031020-2023-00187
Device Sequence Number1
Product Code HRS
UDI-Device Identifier04546540594013
UDI-Public04546540594013
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/30/2022
Device Catalogue Number53-27624S
Device Lot Number1000263492
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/19/2023
Initial Date FDA Received05/15/2023
Supplement Dates Manufacturer Received06/15/2023
10/30/2023
Supplement Dates FDA Received07/11/2023
11/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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