MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0280S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	03/08/2022
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
It was reported that a nail broke, resulting in bha revision surgery.The break was noticed during a regular checkup and it was also noted that there was delayed union of the fracture.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, matches the alleged failure.The received nail is completely broken in the webs of the proximal lag screw hole.Significant drill marks, with chamfer-like material removal, were observed on the lateral side of the proximal end and progressing inside the proximal drill hole towards the medial side.The drill marks were generated by a deviated lag screw step drill which created the starting point of the fracture (notching effect) where a sharp edge was formed in the posterior web, which indicates misdrilling.Another thing to note apart from the drill marks was the sign of increased loading which is also evident from material deformation at the medial, inferior, side of the distal nail fragment where the material is deformed.The fracture pattern resembles a fatigue fracture, evident by the appearance of rest lines missing plastic deformation and ductile residual fracture.The incipient crack had been caused by intra-operative damage creating a sharp edge in the weakest area of the posterior web.From the available radiographs, a medical opinion was requested, from the preoperative x-ray, we can see a highly instable pertrochanteric fracture with a large medial fragment and loss of medial buttress function.The placement of the device is good in all planes.The surgeons have refrained from repositioning the lesser trochanter.A little fracture gap can be identified in the ap plane at the proximal end of the pertrochanteric fracture with dislocated lesser trochanter.There is no obvious severe bone density problem.However, the fracture is a defining fracture for osteoporosis which is feasible in this age group.It looks as if the main factor is patient related as the fracture is highly instable as there is no medial support of the bone due to the dislocated trochanteric fragment.Bone quality is not particularly bad as we do not see any loosening or migration of the nail or the screw.Optimized reduction with compression in the fracture gap could have improved the situation and thus brought about earlier bone healing.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 the case presented nail breakage had occurred after an implantation period of approx.3 months.Provided x-rays were presented to a medical professional for review.In his opinion no severe medical deficiencies were apparent; only repositioning could have been performed more anatomically.A sem examination was not performed since already macroscopic evidence clearly identified a fatigue fracture.The incipient crack was located at the posterior web at the lateral where intra-operative material damage had caused a sharp edge ¿ reducing the material¿s durability significantly.This was regarded as user related.A contributing factor was usual but high load application by the patient during the implantation period.With available information results a deficiency of the device was not verified.In case further significant information becomes available we reserve the right to re-open the file and to re-assign the root cause.
Event or Problem Description
It was reported that a nail broke, resulting in bha revision surgery.The break was noticed during a regular checkup and it was also noted that there was delayed union of the fracture.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15237939
• Report Number: 0009610622-2022-00377
• Device Sequence Number: 6292896
• Product Code: HSB
• UDI-Device Identifier: 04546540375315
• UDI-Public: 04546540375315
• 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
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 07/31/2020
• Device Model Number: 3425-0280S
• Device Catalogue Number: 34250280S
• Device Lot Number: K097C98
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2015
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 58 KG