MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, RECON T2 RECON Ø6.5X95 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1897-6095S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during surgery the surgeon took an x ray and it showed the screw had broke.Surgeon used one lag screw in t2 alpha recon mode, then left the head of the broken screw in the nail threads as was unable to remove and finished the case by using one of the antegrade mode screw hole options." there was a 15 minute delay to the surgery.
Event or Problem Description
As reported: "during surgery the surgeon took an x ray and it showed the screw had broke.Surgeon used one lag screw in t2 alpha recon mode, then left the head of the broken screw in the nail threads as was unable to remove and finished the case by using one of the antegrade mode screw hole options.".There was a 15 minute delay to the surgery.
Additional Manufacturer Narrative
Correction - please refer to d9/h3 - the product was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no medical records confirmed the event.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.In the case presented a patient was treated with above implant for an unknown kind of fracture.It was reported during surgery the surgeon took an x ray and it showed the screw had broke.The surgeon used one lag screw in t2 alpha recon mode, then left the head of the broken screw in the nail threads as he was unable to remove and finished the case by using one of the antegrade mode screw hole options.With available information a root cause could not be determined.If any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: LAG SCREW, RECON T2 RECON Ø6.5X95 MM
• 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: 16010174
• Report Number: 0009610622-2022-00587
• Device Sequence Number: 6578035
• Product Code: HSB
• UDI-Device Identifier: 04546540384799
• UDI-Public: 04546540384799
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1897-6095S
• Device Catalogue Number: 18976095S
• Device Lot Number: K094151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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
• Patient Sex: Unknown