MAUDE Adverse Event Report: STRYKER GMBH FULL RING HOFFMANN LRF Ø180MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49332180
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: ring broke on hlrf frame in patient home.The patient noticed a noise on christmas eve and then attended clinic on new year's eve for review.Decision remains outstanding as to whether or not patient will be revised (adverse consequences).
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: ring broke on hlrf frame in patient home.The patient noticed a noise on christmas eve and then attended clinic on new year's eve for review.Decision remains outstanding as to whether or not patient will be revised (adverse consequences).
Additional Manufacturer Narrative
Correction - please refer to b2, h1, d9 - the device was not returned.The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was returned and h6 (method and results codes).The complaint could be confirmed, since the information for evaluation matches the alleged failure.The device inspection revealed the following: visual examination of the construction received has shown that 3 products are broken.One full ring ø180mm and two static strut.Visual examination of the received full ring ø180mm shows that is broken as reported.In addition, it is visible that the breakage section is fixed to no movement in dislocated position.Investigator reviewed the received information together with engineering and noted: unfortunately, we received no information or image of the complete hoffman lrf construct, nor any details on how it was installed on the patient.Therefore, we cannot understand how all the parts were assembled.The assembly with the three broken parts was most likely an unstable construct, and the parts had to withstand a great deal of force, which led to the three fractures.After the fractures, additional stabilizing material was most likely added, such as the two static struts at the ring fracture to stabilize it, and a threaded rod between the broken static struts to further stabilize it.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.Although the issue is most likely related to procedure, the root cause could not be conclusively determined.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: ring broke on hlrf frame in patient home.The patient noticed a noise on christmas eve and then attended clinic on new year's eve for review.Decision remains outstanding as to whether or not patient will be revised (adverse consequences).01/16/2026 - two additional devices were received upon product return.Both devices are broken as well.

• Brand Name: FULL RING HOFFMANN LRF Ø180MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21260502
• Report Number: 0008031020-2025-00226
• Device Sequence Number: 18156515
• Product Code: KTT
• UDI-Device Identifier: 07613252610625
• UDI-Public: (01)07613252610625(11)240219(10)6459AA
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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: 49332180
• Device Lot Number: 6459AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 01/26/2026
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/19/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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; Required Intervention
• Patient Sex: Unknown