MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35250320S
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	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : product will be discarded at the hospital.
Event or Problem Description
As reported: "due to poor reduction at the primary surgery on (b)(6) 2023 a non-union was occurred and the nail fracture was occurred.Revision surgery is scheduled for replacement of the gamma nail.".
Event or Problem Description
As reported: "due to poor reduction at the primary surgery on (b)(6) 2023 a non-union was occurred and the nail fracture was occurred.Revision surgery is scheduled for replacement of the gamma nail.".
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog #, d4 lot #, d9/h3, h6 method, results and conclusion codes.The reported event could be confirmed, since the device was returned and matches alleged failure.The received nail is completely broken in the webs of the proximal lag screw hole.Slight drill marks were found at the lateral entrance of the hole on the surface of the distal segment.However, the more significant thing to note apart from the drill marks was the sign of overloading.Bearing points of the lag screw at the medial edge of the proximal hole showed significant deformation, indicating towards high compressive load.The breakage pattern indicates the fatigue breakage, having equal portions of fatigue zone and instantaneous zone indicating that the breakage was initiated in a fatigued manner but quickly broke instantaneously under high compressive loading.With available radiograph, a formal medical opinion was sought: "with limited information, we can conclude that this was a very unstable fracture.Without any pre-surgical information about initial surgery, nothing can be stated for the repositioning.It can be indicated that either the repositioning was insufficient or there was a secondary dislocation of the fracture due to the intrinsic instability of the fracture.The continuous movement in the fracture area may lead to non-union and breakage of the nail.This breakage is indeed not device-related, but a multifactorial adverse event due to the fracture pattern, the unstable reconstruction, or other applicable factors that contribute towards the nail failure in this specific case." 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.Based on the available information, the root cause can be attributed to a combination of user and patient related factors.If any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X320MM 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18044280
• Report Number: 0009610622-2023-00382
• Device Sequence Number: 8254536
• Product Code: HSB
• UDI-Device Identifier: 04546540375728
• UDI-Public: 04546540375728
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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 Catalogue Number: 35250320S
• Device Lot Number: K0E954E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: 50 YR
• Patient Sex: Male