MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned , since it is implanted in patient therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
During the insertion of the gamma 4 u lag screw, compression was applied by gently hitting it with a hammer, but the compressed fracture area became deviated.Surgeon was not satisfied with the gap (non union) present in compressed fracture.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was implanted and no other evidence was provided.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.The lag screw insertion was completed successfully.After hammering, the fracture was open but could not be repaired, so the surgery was completed as is.The surgeon was dissatisfied with the gapping of the fracture site.More detailed information about the complaint event, e.G.X-ray in m-l- view, must be available in order to determine the root cause of the complaint event.At the end of the surgery, it is the responsibility of the surgeon if he leaves the patient as is.Based on investigation, the root cause was attributed to a user related issue.With available information a product deficiency was not verified.In case we receive further substantial information we reserve the right re-open the case and to re-assess the root cause.
Event or Problem Description
During the insertion of the gamma 4 u lag screw, compression was applied by gently hitting it with a hammer, but the compressed fracture area became deviated.Surgeon was not satisfied with the gap (non union) present in compressed fracture.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X90MM
• 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: 19625781
• Report Number: 0009610622-2024-00310
• Device Sequence Number: 8085124
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: 07613327591804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: Health Professional
• Device Catalogue Number: 81660090S
• Device Lot Number: K1B2812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• 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: Other
• Patient Sex: Female
• Patient Weight: 70 KG