MAUDE Adverse Event Report: STRYKER GMBH TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED); APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49330180

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2024

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "pin/bolt detached from the strut, this was found at the patient's home (70 years old).Surgery date was (b)(6) 2023.Since then full weight bearing, on (b)(6) 2024 the patient came for a check-up, where it was diagnosed.Removal of the fixator was (b)(6) 2024, the event did not influence the result.".

• Brand Name: TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED)
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 18969487
• MDR Text Key: 338499377
• Report Number: 0008031020-2024-00130
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613252610236
• UDI-Public: 07613252610236
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113327
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 49330180
• Device Lot Number: K75214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 70 YR