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

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.

• 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 Key: 16930702
• MDR Text Key: 315204556
• Report Number: 0008031020-2023-00187
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540594013
• UDI-Public: 04546540594013
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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 Date: 06/30/2022
• Device Catalogue Number: 53-27624S
• Device Lot Number: 1000263492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 10/30/2023
• Supplement Dates FDA Received: 07/11/2023; 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female