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

Catalog Number	35251400S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544); Limb Fracture (4518); Implant Pain (4561)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported: "i would like to contact you regarding the attached report on a gamma nail.Breakage of the nail and distal screw when the patient moves (walking) no notion of trauma.Devices involved: two.Clinical consequences observed: secondary fracture displacement.Functional impotence + pain.Protective measures and actions taken: removal of the nail and fitting of another nail + gtr hook".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported: "i would like to contact you regarding the attached report on a gamma nail.Breakage of the nail and distal screw when the patient moves (walking) no notion of trauma.Devices involved: two.Clinical consequences observed: secondary fracture displacement functional impotence + pain protective measures and actions taken: removal of the nail and fitting of another nail + gtr hook".
Additional Manufacturer Narrative
Corrections: d4 lot# and d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence 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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT 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: 18981205
• Report Number: 0009610622-2024-00110
• Device Sequence Number: 6693885
• Product Code: HSB
• UDI-Device Identifier: 07613252274315
• UDI-Public: 07613252274315
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/24/2024

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 Catalogue Number: 35251400S
• Device Lot Number: K0BF795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2021
• 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