MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/27/2022
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 gamma nail broke and had to be explanted.Revision surgery was performed.
Additional Manufacturer Narrative
Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More information such as patient details as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a gamma nail broke and had to be explanted.Revision surgery was performed.
Additional Manufacturer Narrative
Please note the corrections to d9/h3 as the device was returned for evaluation.Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.On the anterior web, very slight mis-drilling marks are visible but no visible material damage due to it can be observed.However, bearing points of lag screw at the lateral edge of the proximal part showed severe deformation.The medial edge of the distal part also showed signs of deformation, much heavier than the proximal one.This indicates towards application of high compressive load.This is also evident by the appearance of heavy deformation at the distal screw holes on the superior aspect.The fracture pattern resembles a fatigue fracture, evident by a rather smooth sur-face and appearance of shiny surface.The breakage initiated in a fatigue manner from the anterior side but broke in a much quicker manner from the posterior side due to high tension and loading.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.Based on the above investigation and the available information, the root cause of the issue is deemed to be patient related.Severe material deformation of the lateral and medial edges of the proximal hole and occurrence of a fatigue fracture indicates towards a potential overloading of the whole construct, ultimately leading to breakage of the nail as well as the distal locking screw.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a gamma nail broke and had to be explanted.Revision surgery was performed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM 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: 14786389
• Report Number: 0009610622-2022-00275
• Device Sequence Number: 5058547
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2022

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: 10/31/2024
• Device Model Number: 3525-1360S
• Device Catalogue Number: 35251360S
• Device Lot Number: K044FD7
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 07/20/2022; 11/29/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/18/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• 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: Unknown