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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the company representative that it was discovered during a second surgery, the plate was broken.Plate was removed and replaced.No other information is known at this time.
Event or Problem Description
It was reported by the company representative that it was discovered during a second surgery, the plate was broken.Plate was removed and replaced.No other information is known at this time.
Additional Manufacturer Narrative
The investigation results show that the postoperative implant fracture occurred through the welding seam, so the reported event could be confirmed.The (measurable) dimensions of the returned implant are in accordance with the specifications.The chemical composition conforms to the specification of ti grade 4.The macroscopic and microscopic investigation show that the implant was bent and re-bent during the adaptation to the anatomy of the patient in the area where the plate meets the bar.This caused a massive local strain hardening / embrittlement of the material and resulted finally in the fracture of the device in forced rupture mode.That is confirmed by the deterioration of the anodization layer, the changes of the surface¿s structure and the secondary cracks in the area of the breakage.Further x-rays were requested, but it was not possible to provide them by the customer.The implant was implanted for 9 days and the implant was bent by hand.The result of the visual evaluation and the inspection show that high bending forces were applied to the welding seam where the plate meets the bar during the adaptation to the patient.Due to the weakened area, most likely the implant could not withstand the forces acted postoperative on the implant.As stated in the related ifu, the implant must not be bend over the welding seam where the plate meets the bar.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.

• 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
• MDR Report Key: 11807811
• Report Number: 0008010177-2021-00029
• Device Sequence Number: 3632859
• Product Code: DZE
• UDI-Device Identifier: 04546540435675
• UDI-Public: 04546540435675
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K041651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 55-06161
• Device Catalogue Number: 55-06161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention