MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, TI GAMMA3 Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600095S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Perforation (2001); Confusion/ Disorientation (2553)
Date of Event	05/02/2024
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
The customer reported to the following: "on (b)(6) 2023, an orthopaedic surgeon at our hospital, treated an 80-year-old patient for a per trochanteric fracture of the right femur, for which he recommended surgery with a gamma stryker nail.Postoperative recovery was straightforward, with satisfactory follow-up x-rays.The patient was seen again at 6 weeks, with no particularities, and gradually returned to full weight-bearing.The patient was not seen again at 3 months; he was referred to our establishment's emergency department for repeated falls and confusion on 27/04/2024.On (b)(6) 2024, the surgeon noted on the x-ray taken on admission that the cervical screw of the trochanteric nail had literally "self-screwed" through the joint space and ended up against the quadrilateral blade of the pelvis.The surgeon noted: mobilisation of the cervical screw of the trochanteric nail of the trochanteric nail having literally "self-crevised" to cross the joint space and finish its course against the quadrilateral blade of the pelvis, i.E.It has not "yet" penetrated the pelvis.On clinical examination, the hip can be moved in but not in moderately sensitive rotation.The patient was rushed to the operating theatre for removal of the gamma nail.Prolonged hospitalisation and need for an operation to remove the material and a new surgery scheduled for hip replacement.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received nail, lag screw, and set screw were visually inspected in which we can see heavy deformation at the proximal end of the nail, the deformation at the lag screw insertion point can be seen from the drill hitting the nail which can also be confirmed with the marking on the lag screw which indicates that the lag screw was rubbing around the nail as all the coating is been rubbed off.While looking at the closure at the set screw insertion point the proximal walls are deformed, at the insertion thread, we see heavy deformation which may indicate misalignment at the insertion point.From the damage observed at the distal end of the set screw and the dent mark on the lag screw groove, it is evident that the set screw was not properly aligned into the grooves it was hitting on the side of the grooves.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 above investigation root cause can be attributed to the user-related as the locking of lag screw was not proper which is evident from the set screw marking along the side of the groove not in the groove and damage at the set screw.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported to the following: "on (b)(6)2023, an orthopaedic surgeon at our hospital, treated an 80-year-old patient for a per trochanteric fracture of the right femur, for which he recommended surgery with a gamma stryker nail.Postoperative recovery was straightforward, with satisfactory follow-up x-rays.The patient was seen again at 6 weeks, with no particularities, and gradually returned to full weight-bearing.The patient was not seen again at 3 months; he was referred to our establishment's emergency department for repeated falls and confusion on (b)(6)2024.On (b)(6)2024, the surgeon noted on the x-ray taken on admission that the cervical screw of the trochanteric nail had literally "self-screwed" through the joint space and ended up against the quadrilateral blade of the pelvis.The surgeon noted: mobilisation of the cervical screw of the trochanteric nail of the trochanteric nail having literally "self-crevised" to cross the joint space and finish its course against the quadrilateral blade of the pelvis, i.E.It has not "yet" penetrated the pelvis.On clinical examination, the hip can be moved in but not in moderately sensitive rotation.The patient was rushed to the operating theatre for removal of the gamma nail.Prolonged hospitalisation and need for an operation to remove the material and a new surgery scheduled for hip replacement.".

• Brand Name: LAG SCREW, TI GAMMA3 Ø10.5X95MM
• 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: 19448437
• Report Number: 0009610622-2024-00263
• Device Sequence Number: 12948563
• Product Code: HSB
• UDI-Device Identifier: 04546540374936
• UDI-Public: 04546540374936
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 30600095S
• Device Lot Number: K1637EA
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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 Age: 80 YR
• Patient Sex: Male