MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3330-0340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
In the context of the implantation of a gammanagel long nail gamma3 r2.0, ti, 11x340 mm/130° left (3330-0340) ce 0123k042a3a, we have received a lawyer's letter.According to this letter, the gamma nail, which was implanted on (b)(6) 2022, broke only a few weeks later and was replaced on (b)(6) 2022.The patient was implanted with a new gamma nail with a length of 360 mm as part of the revision surgery.The patient is not allowed to bear weight until (b)(6) 2022 and was set back overall in her recovery process.Mobilization will be significantly more complex.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned, however pictures were received for inspection.The evidence inspection revealed the following: the identification of the device was confirmed based on the catalog # and the lot # marked.From the pictures received, it could be confirmed that the nail is broken in two parts, around the proximal locking hole.The functionality of the implant cannot be given anymore and the reported failure was confirmed.Multiple wear marks are visible around the proximal hole.However, the fractured area is not clearly visible as no picture of the breakage was received.Therefore, no inspection of the breakage could be performed and no statement could be made regarding the cause of the failure.No other information regarding the breakage and the patient¿s condition was provided.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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
In the context of the implantation of a gammanagel long nail gamma3 r2.0, ti, 11x340 mm/130° left (3330-0340) ce 0123k042a3a, we have received a lawyer's letter.According to this letter, the gamma nail, which was implanted on (b)(6) 2022, broke only a few weeks later and was replaced on 06-jul-2022.The patient was implanted with a new gamma nail with a length of 360 mm as part of the revision surgery.The patient is not allowed to bear weight until (b)(6) 2022 and was set back overall in her recovery process.Mobilization will be significantly more complex.
Event or Problem Description
In the context of the implantation of a gammanagel long nail gamma3 r2.0, ti, 11x340 mm/130° left (3330-0340) ce 0123k042a3a, we have received a lawyer's letter.According to this letter, the gamma nail, which was implanted on (b)(6) 2022, broke only a few weeks later and was replaced on (b)(6) 2022.The patient was implanted with a new gamma nail with a length of 360 mm as part of the revision surgery.The patient is not allowed to bear weight until (b)(6) 2022 and was set back overall in her recovery process.Mobilization will be significantly more complex.
Additional Manufacturer Narrative
Please note the correction to h6 conclusion code.The reported event could be confirmed based on the evidence received.The device was not returned, however pictures of the implant, x-rays and medical reports were received for inspection.The evidence inspection revealed the following: the identification of the device was confirmed based on the catalog # and the lot # marked.From the pictures received, it could be confirmed that the nail is broken in two parts, around the proximal locking hole.The functionality of the implant cannot be given anymore and the reported failure was confirmed.Multiple wear marks are visible around the proximal hole.However, the fractured area is not clearly visible as no picture of the breakage was received.Therefore, no detailed inspection of the breakage could be performed.X-rays inspection and medical expert opinion: the lesser trochanteric and subtrochanteric fractures reported in the medical records were confirmed based on the x-rays received.The post-operative x-rays confirmed that the nail breakage occurred approximately 4 months after implantation.The type fracture observed is highly complex, needing a very stable construct for healing.The delayed union / non union of the fractures observed in the lesser trochanter and the subtrochanter were most likely the main cause of the nail breakage.The limited amount of callus observed after 4 months of implantation suggests a non-union.Looking distally there is a periostal reaction around the (proximal) distal screw.This indicates there was movement of the screw during the healing phase.The continuous movement may have been one of the causes for the non-union.This may have lead to fatigue and nail breakage.The medical records did not indicate if the patient suffers from a major health problem and they confirm that the post-operative indications were followed.Based on investigation, the root cause was attributed to a patient condition related issue.The delayed union/non union of the fractures in the proximal part of the femur lead to excessive loads being applied to the implant, causing its failure.As a reminder, a nail will be subjected to a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 130°
• 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: 15470189
• Report Number: 0009610622-2022-00439
• Device Sequence Number: 4468621
• Product Code: HSB
• UDI-Device Identifier: 07613153313748
• UDI-Public: 07613153313748
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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: 08/31/2023
• Device Model Number: 3330-0340S
• Device Catalogue Number: 33300340S
• Device Lot Number: K042A3A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 04/12/2023
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/24/2022; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2018
• 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: 71 YR
• Patient Sex: Female