MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T7, 2.7X14MM; PLATE, FIXATION, BONE

Catalog Number	53-27214S
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
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.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.H3 other text : device remains implanted.

• Brand Name: BONE SCREW, T7, 2.7X14MM
• 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; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18132908
• Report Number: 0008031020-2023-00397
• Device Sequence Number: 7753290
• Product Code: HRS
• UDI-Device Identifier: 04546540593870
• UDI-Public: 04546540593870
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 53-27214S
• Device Lot Number: 1000275887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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