MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG RECON, HEMI, MAND, PLATE, LEFT WITH TEMPLATE, 6X17 HOLE, STERILE; IMPLANT

Catalog Number	11-28926
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2018
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 the recon plate fractured at an angled position post-operatively.It is unknown what further actions were taken; however, it is likely to assume that medical intervention will occur.
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 changes of the surface¿s structure and the secondary cracks in the area of the breakage.The fracture surfaces were partially leveled due to friction with the counterpart.The non-destroyed fracture surfaces (rest) shows the appearance of a forced rupture.Furthermore, there is a crack line through the entire plate.On the edge of each fracture surface and the related bottom side, there are secondary cracks.Furthermore, the bottom surface of fragment # 2 in the area of the breakage shows very strong deformation resulting from medical instruments.The fractographic investigation with sem shows a structure of a ductile forced rupture with secondary cracks and in addition, swinging lines of a fatigue breakage are visible.Most likely the very strong deformations / dents due to medical instruments might have contributed the plate breakage.Scratching or damage to the implant can significantly reduce the strength and fatigue resistance of the product.All relevant quality documents (manufacturing and inspection documents) have been reviewed.The device history record for article# 11-28926 with lot/batch code# 1000280800 indicates (b)(4) devices were manufactured and accepted into final stock on 2017-nov-30.No issues could be found in the manufacturing or inspection documents.Initially the case was reported with minimal information.A non-stryker third party distributor was the direct contact to the reporting healthcare facility and various requests were addressed in order to gain more insight into the reported incident / to track essential case details.Finally, sufficient feedback has been received and the requested x-rays were provided.Information and images were forwarded to the clinical expert for evaluation.Based on his assessment in this case there was nothing wrong with the surgical technique.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.
Event or Problem Description
It was reported that the recon plate fractured at an angled position post-operatively.It is unknown what further actions were taken; however, it is likely to assume that medical intervention will occur.

• Brand Name: RECON, HEMI, MAND, PLATE, LEFT WITH TEMPLATE, 6X17 HOLE, STERILE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8627368
• Report Number: 0008010177-2019-00019
• Device Sequence Number: 2293104
• Product Code: JEY
• UDI-Device Identifier: 07613154716319
• UDI-Public: 07613154716319
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• 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: 11-28926
• Device Lot Number: 1000280800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/21/2019
• 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