MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, LEFT, 5+17-HOLES, WITH TEMPLATE; IMPLANT

Catalog Number	55-15922
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
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 that after an initial surgery on (b)(6) 2013, the mandibular reconstruction plate fractured without any notion of trauma nor closing force.
Event or Problem Description
It was reported that after an initial surgery on (b)(6) 2013, the mandibular reconstruction plate fractured without any notion of trauma nor closing force.
Additional Manufacturer Narrative
The 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.The chemical composition conforms to the specification of ti grade 2.The macroscopic appearance points to exceeding the material strength.That is confirmed by the deterioration of the anodization layer, the secondary cracks and the changes of the surface¿s structure in the area of the breakage.Strong plastic deformation with material bulging indicate high forces acted on the plate during application.Further some marks/scratches and a crack point to exceeding the material strength due to very high forces due to applying medical instruments.The fracture surfaces were partially leveled due to friction with the counterpart.The non-destroyed fracture surfaces (rest) show the appearance of a forced rupture.The fractographic investigations with sem show a structure of a ductile forced rupture with secondary cracks and in addition, swinging lines of a fatigue breakage are visible.No lot number was provided and a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.However, the investigation steps conducted and the further provided information demonstrate much evidence that the event is not related to a manufacturing issue.To obtain more details about the complained event, the sales rep was contacted.Unfortunately, after several attempts no further information (as x-rays, primary or secondary reconstruction performed) was provided.The stryker cmf¿s stryker health care professional was contacted in order to assess the provided information (the last 3 holes on each end show signs of use - screws had been inserted for fixation): ¿(¿) the way the screws were inserted it looks like a ¿secondary¿ reconstruction for comminuted fracture rather than for a simple fracture, so a secondary recon plate should have been used if such was the case.(¿)¿ because it has not been reported whether a primary or a secondary reconstruction was performed, it cannot be determined if the plate was used as intended.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.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

• Brand Name: PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, LEFT, 5+17-HOLES, WITH TEMPLATE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8693125
• Report Number: 0008010177-2019-00035
• Device Sequence Number: 19334283
• Product Code: JEY
• UDI-Device Identifier: 04546540356406
• UDI-Public: 04546540356406
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: 55-15922
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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