MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MANDIBULAR FRACTURE PLATE, 6-HOLES, WITH BAR, PROFILE HEIGHT 2.0MM; IMPLANT

Model Number	92-55508
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	05/31/2021
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 the plate broke post-op.There is a revision surgery scheduled to replace the broken plate.
Event or Problem Description
It was reported by the company representative that the plate broke post-op.There is a revision surgery scheduled to replace the broken plate.
Additional Manufacturer Narrative
The device was returned to the manufacturer and investigation results show that the postoperative plate fracture occurred through a bar, so the reported event could be confirmed.The (measurable) dimensions of the returned plate are in accordance with the specifications and the chemical composition conforms to the specification of ti grade 2.The macroscopic appearance points to exceeding the material strength and that is confirmed by the deterioration of the anodization layer, the changes of the surface¿s structures as well as the secondary cracks in the area of the breakage.The fracture surfaces were partially leveled due to friction with the counterpart and the non-destroyed fracture surfaces (rest) show the appearance of a forced rupture.The fractographic investigations show structures of a ductile forced rupture with secondary cracks and in addition, swinging lines of a fatigue breakage are visible.To obtain more details about the complained event and the device under complaint (e.G.Lot number, pre- and postoperative x-rays), the sales rep was contacted.The instrumentation options the surgeon did have in his set are adequate to be used to bend the plate under complaint.Related to the event in question, a review of additional documentation (x-rays) was performed.The x-ray provided was forwarded to stryker¿s senior global medical director along with the complaint information.He stated the plate has been implanted correctly.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: MANDIBULAR FRACTURE PLATE, 6-HOLES, WITH BAR, PROFILE HEIGHT 2.0MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 12193676
• Report Number: 0008010177-2021-00038
• Device Sequence Number: 19730445
• Product Code: JEY
• UDI-Device Identifier: 07613154750771
• UDI-Public: 07613154750771
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• 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): 08/30/2021

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: No Information
• Device Model Number: 92-55508
• Device Catalogue Number: 92-55508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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