MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN CANCELLOUS SCREW PARTIALLY THREADED 4.0 X 45MM; SCREW, FIXATION, BONE

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Discomfort (2330); Deformity/ Disfigurement (2360); Numbness (2415); Implant Pain (4561)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2020, the patient underwent open reduction and internal fixation due to bimalleolar ankle fracture, left and was implanted with various stryker plates and screws.Allegedly the patient continued to experience persistent pain, discomfort, and other complications.Allegedly the patient has limited rom, numbness and his left ankle was and remains severely and noticeably disfigured.

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device remains implanted in patient.

• Brand Name: UNKNOWN CANCELLOUS SCREW PARTIALLY THREADED 4.0 X 45MM
• Type of Device: SCREW, 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: 14944112
• MDR Text Key: 295406236
• Report Number: 0008031020-2022-00322
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2022

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 Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/07/2022
• 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): Other
• Patient Sex: Male