MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "breakage of the dm detected by x-ray examination.It should be noted that the patient is under pharmacological treatment for osteoporosis.Six months after the operation, retrotrochanteric pain in the operated limb is reported without trauma.Following x-ray, a rupture of the dm was detected.Revision on (b)(6) 2023 for nail removal and prosthetic implant plus plates and cerclages.".
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: "breakage of the dm detected by x-ray examination.It should be noted that the patient is under pharmacological treatment for osteoporosis.Six months after the operation, retrotrochanteric pain in the operated limb is reported without trauma.Following x-ray, a rupture of the dm was detected.Revision on (b)(6) 2023 for nail removal and prosthetic implant plus plates and cerclages.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device returned and is indeed broken.The devices returned include a long gamma nail, a lag screw, a set screw and a distal locking screw.The catalog and lot numbers reported could be confirmed.The nail was indeed confirmed to be broken in two at the level of the lag screw hole.On the proximal broken part, on the inside wall of the lag screw hole, misdrilling marks can be noticed, indicating that the nail was hit by the drill during the preparation of the lag screw hole.A fracture analysis of the broken bridges shows clear rest lines going from the lateral to the medial side, highlighted in red below.These rest lines are clear indicators of a fatigue fracture.The fracture most probably started when the drill hit the nail during the preparation of the lag screw hole, introducing a fracture that propagated during the use of the product, and leading to a total breakage of the two parts of the nail.Based on investigation, the root cause was attributed to be user related.The misdrilling which happened during the preparation of the lag screw hole preparation is the most probable root cause of the fatigue fracture of the nail.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM 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: 17901230
• Report Number: 0009610622-2023-00348
• Device Sequence Number: 3366818
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 35251360S
• Device Lot Number: K0E86F4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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: 87 YR
• Patient Sex: Female