MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES; PLATE, FIXATION, BONE

Catalog Number	54-25384S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Skin Inflammation/ Irritation (4545); Implant Pain (4561)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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 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.
Event or Problem 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.
Additional 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.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES
• Common Device Name: 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 Key: 16930705
• Report Number: 0008031020-2023-00185
• Device Sequence Number: 20513231
• Product Code: HRS
• UDI-Device Identifier: 04546540578716
• UDI-Public: 04546540578716
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/11/2022
• Device Catalogue Number: 54-25384S
• Device Lot Number: 1000278704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 10/30/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/11/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female