MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG ANCHOR PLATE,STANDARD,STRAIGHT,LONG; IMPLANT

Model Number	55-06161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported the plate was implanted successfully and then later noticed the plate had broke.A second surgery was performed and a temporary device was put in place.
Additional Manufacturer Narrative
Although the plate was not available for investigation, a picture of the broken off fragment was provided.Therefore, the postoperative breakage of the plate can be confirmed.To gain additional information about the reported event, the surgeon was contacted.All further provided information did not show any deviations from the instruction for use.H3 other text : not available.
Event or Problem Description
It was reported the plate was implanted successfully and then later noticed the plate had broke.A second surgery was performed and a temporary device was put in place.

• Brand Name: ANCHOR PLATE,STANDARD,STRAIGHT,LONG
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16815954
• Report Number: 0008010177-2023-00023
• Device Sequence Number: 20254728
• Product Code: DZE
• UDI-Device Identifier: 04546540435675
• UDI-Public: 04546540435675
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: Health Professional
• Device Model Number: 55-06161
• Device Catalogue Number: 55-06161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/27/2023
• 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 Sex: Unknown