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

Catalog Number	34250320S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Cancer (3262)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
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: "breast cancer patient, case of meta.Primary surgery with long gamma on (b)(6) 2021.Postoperatively, radiotherapy to the affected area.Currently tumor marker 0.As of (b)(6) 2023, there is no fusion and the fracture area appears to be slightly more open than it was immediately after surgery.Nail fracture was confirmed on (b)(6) 2023.
Additional Manufacturer Narrative
Kt / 20 nov 2023: please note correction to h3 - "device evaluated by mfg" was changed to "yes".Some imdrf-codes were updated according to investigation conclusion.The reported event could be confirmed, since the device was returned, and matches the alleged failure.With the available radiographs, a formal medical opinion was sought:- two difficulties in this pathological fracture, there seems to be a metastasis from the breast cancer in the bone and a subtrochanteric (reverse) type of fracture.With the available quality and one direction of radiographs, it is difficult to conclude the healing phase of fracture.The non-union most probably caused the nail to break in a fatigue manner.The received nail is completely broken in the webs of the proximal lag screw hole.We can see the misdrilling marks at the proximal end of the nail and heavy the load-bearing points at the medial edge.We can see lines of rest which indicate that the initiation of breakage happened in a fatigued manner, which is caused by the frequent movement at the lag screw junction which created the heavy load bearing point.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 investigation, the root cause was attributed to a combination of patient and user related factors.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "breast cancer patient, case of meta.Primary surgery with long gamma on (b)(6) 2021.Postoperatively, radiotherapy to the affected area.Currently tumor marker 0.As of (b)(6) 2023, there is no fusion and the fracture area appears to be slightly more open than it was immediately after surgery.Nail fracture was confirmed on (b)(6) 2023.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT 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 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: 17799760
• Report Number: 0009610622-2023-00330
• Device Sequence Number: 17857345
• Product Code: HSB
• UDI-Device Identifier: 04546540375339
• UDI-Public: 04546540375339
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 08/31/2026
• Device Catalogue Number: 34250320S
• Device Lot Number: K07D161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Race: Asian