MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø10X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250400S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Through a clinical study it was reported that: "deep vein thrombosis.Chronic, recurrent dvts in proximal veins of both lower extremities.History of dvt episodes precedes gamma-4 surgery date.Action taken: yes.Medication.Treatment: inr 1.7, on coumadin with filter.No indication for hospitalization.".
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.H3 other text : device disposition is unknown.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.The provided details were forwarded to an hcp for review and statement ¿ (excerpts): ¿ae is okay, but not device related.At best, procedure or thrombosis caused by immobilization.The patient seems to have a long, chron.History of dvt.(¿) but the problem is, as i said, not due to the implant itself.¿ furthermore, complications (e.G., thrombosis / thrombus) are clearly pointed out under chapter ¿adverse events and effects¿ and rather clinical than device related.With the given details no further technical statement could be given.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
Through a clinical study it was reported that: "deep vein thrombosis chronic, recurrent dvts in proximal veins of both lower extremities.History of dvt episodes precedes gamma-4 surgery date.Action taken: yes.Medication treatment: inr 1.7, on coumadin with filter.No indication for hospitalization.".

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø10X400MM 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: 19201799
• Report Number: 0009610622-2024-00177
• Device Sequence Number: 7952789
• Product Code: HSB
• UDI-Device Identifier: 07613327477764
• UDI-Public: 07613327477764
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 85250400S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 84 YR
• Patient Sex: Female