MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HAND PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Numbness (2415); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/26/2022

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.Device remains implanted in patient.

Event Description

As reported: "on (b)(6) 2022 my wife was operated on her broken left- wrist in spain after a sports accident.During the operation a plate (and screws) were inserted.This plate (and screws) still cause her pain and numbness in three fingers of her left hand.Immediately after the surgery ((b)(6) 2022), my spouse advised the surgeon of the wrist pain and numbness.Only an x-ray was taken on (b)(6) 2022.Since her pain persisted at home, a hand specialist, was consulted.It was proven by cts (ct scans) that the plate together with the screws had been inserted incorrectly (in this case: screws screwed too far into the joints!).As a result, the cartilage layer between the joints was destroyed and a partial fusion of the left wrist will have to be performed in a new operation.If this plate/screws are a class 3 medical device, they are either not suitable for this medical application or have been inserted incorrectly (too long, possibly not sterile).My wife's health has been severely affected.Her left wrist will remain damaged forever.".

Event Description

As reported: "on (b)(6) 2022 my wife was operated on her broken left- wrist in spain after a sports accident.During the operation a plate (and screws) were inserted.This plate (and screws) still cause her pain and numbness in three fingers of her left hand.Immediately after the surgery ((b)(6) 2022), my spouse advised the surgeon of the wrist pain and numbness.Only an x-ray was taken on (b)(6) 2022.Since her pain persisted at home, a hand specialist, was consulted.It was proven by cts (ct scans) that the plate together with the screws had been inserted incorrectly (in this case: screws screwed too far into the joints!).As a result, the cartilage layer between the joints was destroyed and a partial fusion of the left wrist will have to be performed in a new operation.If this plate/screws are a class 3 medical device, they are either not suitable for this medical application or have been inserted incorrectly (too long, possibly not sterile).My wife's health has been severely affected.Her left wrist will remain damaged forever.".

Manufacturer Narrative

The received pictures were reviewed and it can be confirmed that the visible plate is not a stryker device.The pictures show a extract with laser markings of a blue anodized plate, the markings show the catalog number dtgvn3, a lot- or serial number (b)(6) and a company logo that has the letters "nct" in a circle.A internet search has shown that this is a 2.4 hybrid plate for distal radius from the manufacturer newclip technics, see page 26 of the attached brochure.Therefore, no further evaluation of this complaint is required from a stryker standpoint.If any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN HAND PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16186223
• MDR Text Key: 307505856
• Report Number: 0008031020-2023-00021
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female