MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1320S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "broken gamma nail, 2 months post-surgery.Need a second medical procedure.Revision of gamma nail + u-blade column screw." update: when walking from toilet to the kitchen the patient suffered acute severe pain.She had to sit down and could no longer load the leg.
Event or Problem Description
As reported: "broken gamma nail, 2 months post-surgery.Need a second medical procedure.Revision of gamma nail + u-blade column screw." update: when walking from toilet to the kitchen the patient suffered acute severe pain.She had to sit down and could no longer load the leg.
Additional Manufacturer Narrative
The reported event could be confirmed.Review of dhr, complaint history, capa databases and risk analysis did not identify any discrepancies.No nc/capa had been filed for the item in question.Potential nail breakage had been considered in the risk management file.Potential reasons for nail breakage are listed in the labelling.Physical investigation of the nail revealed it broke in a fatigue manner, originated by material damage at lateral in the posterior web of the proximal drill hole.Additionally, the nail was significantly loaded during the implantation period.Material and manufacturing deficiencies were not detected.Provided medical information was reviewed by a hcp who found surgical factors (suboptimal fracture reduction, suboptimal positioning of the lag screw) and patient related factors (fracture pattern, presumably poor bone metabolism because of the high age with reduced fracture healing potential, limited musculotendinous equipment due to the preexisting coxarthrosis) which may have contributed to the nail breakage.From technical point of view the event was caused by intraoperative material damage contributed by increased weight bearing.With available information a deficiency of the device was not verified.The cause of the event was determined being intraoperative material damage contributed by the patient.In case further substantive information becomes available we reserve the right to reopen the investigation with root cause assessment.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X320MM 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13156511
• Report Number: 0009610622-2022-00004
• Device Sequence Number: 4118189
• Product Code: HSB
• UDI-Device Identifier: 07613252274261
• UDI-Public: 07613252274261
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 02/28/2025
• Device Model Number: 3525-1320S
• Device Catalogue Number: 35251320S
• Device Lot Number: K04FE17
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG