MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251320S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right femur was revised due to non-union of a femoral neck fracture.Pre-op x-rays also showed a broken distal screw.Intra-operatively, the nail was found to be broken where the lag screw passes through the nail.Patient was revised to a hemi hip construct including a restoration modular stem construct.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text: device retained by hospital.
Additional Manufacturer Narrative
The reported event could be confirmed based on details provided, only.Images provided revealed a broken nail.Due to missing device a physical evaluation was impossible and further technical statement could not be given.In the case presented a 98-year-old female patient, at time of reported event, was revised by a hemi hip construct including a restoration modular stem construct after an implant duration of 3 years and 7 months of final treatment with reported nail kit.Nevertheless, the labelling points out that for successful results a timely bone healing is required; this state must be achieved within a medically recognized period [confirmed by scientific analysis about 6 months] in such a way that the bone strength allows significantly increasing discharge of the time-fixed implant material.Furthermore, delayed union or non-union of the fracture site are clearly pointed out as adverse effects and may be clinical rather than device related.Finally, more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported that the patient's right femur was revised due to non-union of a femoral neck fracture.Pre-op x-rays also showed a broken distal screw.Intra-operatively, the nail was found to be broken where the lag screw passes through the nail.Patient was revised to a hemi hip construct including a restoration modular stem construct.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X320MM 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: 17625249
• Report Number: 0009610622-2023-00293
• Device Sequence Number: 17692688
• Product Code: HSB
• UDI-Device Identifier: 07613252273813
• UDI-Public: 07613252273813
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 34251320S
• Device Lot Number: K03089A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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: Female