MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X420MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3530-1420S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2022
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 long gamma nail broke resulting in a revision surgery.
Event or Problem Description
It was reported that a long gamma nail broke resulting in a revision surgery.
Additional Manufacturer Narrative
Please note the 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 and no additional information was available.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 was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.If any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog #, d1 lot #, d9/h3, h6 method, h6 results and h6 conclusion codes as the device was returned for evaluation.The reported event could be confirmed since the device was confirmed and matches the alleged failure.Device inspection revealed the following: the received nail is found to be completely broken in the webs of the proximal lag screw hole.The fracture appears to have originated from the posterior web in a fatigue manner, as evident by the lines of rest/waves.The anterior web shows signs of instantaneous fracture which is a result of sudden loading after the breakage of the posterior web.Misdrilling marks are also evident majorly on the anterior web, running from lateral entrance to the medial through the bore.Very slight misdrilling marks appear on the anterior web.The breakage is observed in the opposite side of the misdrilling marks.The effect of misdrilling on the breakage in this case cannot be quantified.On the medial side of the distal portion of the nail, the bearing point shows signs of permanent deformation indicating towards overloading of the nail.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.Based on the investigation and the available facts, the root cause of the issue is majorly attributed to patient related factors.The fracture area of the nail exhibits a fatigue fracture and a plastically deformed medial side which indicates towards constant overloading in a cyclic manner.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a long gamma nail broke resulting in a revision surgery.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X420MM 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: 15916044
• Report Number: 0009610622-2022-00570
• Device Sequence Number: 6535802
• Product Code: HSB
• UDI-Device Identifier: 07613252274483
• UDI-Public: 07613252274483
• 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): 04/17/2023

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: 08/31/2026
• Device Model Number: 3530-1420S
• Device Catalogue Number: 35301420S
• Device Lot Number: K0B9F70
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 03/21/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/03/2023; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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