MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251400S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on (b)(6) 2021 the patient tripped and fell and on (b)(6) 2021 she presented for treatment and was diagnosed with a right subtrochanteric femur fracture.Allegedly on (b)(6) 2021 she underwent an intramedullary nail fixation and cerclage wiring in the subtrochanteric region utilizing gamma 3.Allegedly on (b)(6) 2021 the patient developed sudden onset of severe pain in the right hip and it was noted the proximal aspect of the rod was fractured at the location of the proximal compression screw and distal interlocking screw was fractured.Revision surgery was performed on (b)(6) 2021.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
Please note the corrections to d1, d3, d4 catalog #, d4 lot #, h6 results and h6 conclusion codes.The reported event could be confirmed on provided rays.The nail had broken in the webs of the proximal drill hole for the lag screw.The item was not available for physical examination as it is subject to a legal case.Without the nail the kind of breakage could not be determined.It could also not be determined if the nail had been damaged intra-operatively.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Potential causes of nail breakage are listed in the labelling.According to received medical records, incl.X-rays revealed that in this case a today 75-year-old female patient was treated with above nail on (b)(6) 2021 due to a displaced subtrochanteric fracture of the right femur.On (b)(6) 2021 a visit report confirms the bone not to have healed.An operative report stated that the the nail was revised with a competitor¿s nail due to breakage on (b)(6) 2021.Received x-rays and medical records will be reviewed separately by a medical professional.From technical point of view a root cause for nail breakage could not be determined.From medical point of view the fracture pattern, initial insufficient compression and suboptimal treatment due to lateral entry point contributed to the event.If the device is returned or if substantial information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on (b)(6) 2021 the patient tripped and fell and on (b)(6) 2021 she presented for treatment and was diagnosed with a right subtrochanteric femur fracture.Allegedly on (b)(6) 2021 she underwent an intramedullary nail fixation and cerclage wiring in the subtrochanteric region utilizing gamma 3.Allegedly on (b)(6) 2021 the patient developed sudden onset of severe pain in the right hip and it was noted the proximal aspect of the rod was fractured at the location of the proximal compression screw and distal interlocking screw was fractured.Revision surgery was performed on (b)(6) 2021.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM 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: 15072814
• Report Number: 0009610622-2022-00335
• Device Sequence Number: 14827993
• Product Code: HSB
• UDI-Device Identifier: 07613252273851
• UDI-Public: 07613252273851
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• 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): 09/05/2023

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: 03/31/2025
• Device Catalogue Number: 34251400S
• Device Lot Number: K0414D3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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 Sex: Female