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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.".
Event or Problem Description
As reported: "pin/bolt detached from the strut, this was found at the patient's home (70 years old).Surgery date was 12/06/2023.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.".
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The investigation revealed the following: visual examination of the received product shows that it¿s indeed disassembled as reported.Evaluation of the pin shows that it has strong zigzag scratches all over.This zigzag scratches cannot be a result from press-fitting by manufacturing in production, as if press-fitting leave scratches on the pin behind, then they are straight scratches.Such zigzag scratches are normally the result from pulling out with a pendulum movement.The counter part of the pin, the hole were the pin get press-fitted in production, does not show any visual discrepancies.The nut on which the pin rests during use, is severely deformed from the pin, through use.Dimensional inspection: ¿the diameter of the pin got measured, the measure result is within accuracy.¿the diameter of the hole in the tube were the pin was press-fitted by manufacturing.It is no longer possible to check the hole for accuracy after press-fitting, because the hole expands when the pin is pressed in.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED)
• Common Device Name: 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
• Report Number: 0008031020-2024-00130
• Device Sequence Number: 12428766
• Product Code: KTT
• UDI-Device Identifier: 07613252610236
• UDI-Public: 07613252610236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49330180
• Device Lot Number: K75214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown