MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: "patient had an accident on (b)(6) 2023 he underwent surgery and after a few months of surgery and already undergoing physiotherapy, on 02/19/24 he woke up with severe pain in the hip, unable to support the leg on the floor.On that day, he started using braces again and went to the doctor and 'when carrying out tests they found that the gamma3 implant had broken.On (b)(6) 2024, he underwent another procedure to remove the broken implant and placed another gamma3.
Additional Manufacturer Narrative
Correction - please refer to d9 product available to stryker - no.The reported event could not be confirmed, since the device was not returned and no additional information was available.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 as well as the affected device 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.
Event or Problem Description
It was reported: "patient had an accident on (b)(6) 2023 and on (b)(6) 2023 he underwent surgery and after a few months of surgery and already undergoing physiotherapy, on (b)(6) 2024 he woke up with severe pain in the hip, unable to support the leg on the floor.On that day, he started using braces again and went to the doctor and 'when carrying out tests they found that the gamma3 implant had broken.On (b)(6) 2024, he underwent another procedure to remove the broken implant and placed another gamma3.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X380MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19216015
• Report Number: 0009610622-2024-00180
• Device Sequence Number: 8105898
• Product Code: HSB
• UDI-Device Identifier: 07613252274292
• UDI-Public: 07613252274292
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 35251380S
• Device Lot Number: K144D07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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 Sex: Male