MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CUSTOMIZED MAND. RECON PLATE20, HEMI; IMPLANT

Model Number	78-30020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
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 a cci was removed due to patient having cancer return.However, upon opening the site it was noticed that the plate had broke by a screw hole, and it was removed.
Event or Problem Description
It was reported that a cci was removed due to patient having cancer return.However, upon opening the site it was noticed that the plate had broke by a screw hole, and it was removed.
Additional Manufacturer Narrative
The investigation results show that the postoperative plate fracture occurred through a hole, 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 and the changes of the surface¿s structure in the area of the breakage.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.The device history records (design proposal, manufacturing documents, inspection plan, inspection drawing and release report) for article# (b)(4), lot # 1603091006 indicate that 1 patient specific device was manufactured and finally packed on 2016-03-23 with no reported discrepancies.To obtain more details about the complained event, the sales rep was contacted, and several answers received.The stryker cmf¿s stryker health care professional was contacted in order to assess the provided information ¿(¿) looks like a fatigue fracture of the plate.Everything was positioned correctly.(¿)¿ in sum, all performed investigations indicate that the plate broke due to a forced rupture in combination with a fatigue breakage.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: CUSTOMIZED MAND. RECON PLATE20, HEMI
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9233100
• Report Number: 0008010177-2019-00065
• Device Sequence Number: 16887213
• Product Code: JEY
• UDI-Device Identifier: 07613252599647
• UDI-Public: 07613252599647
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132519
• 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): 01/28/2020

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: 78-30020
• Device Catalogue Number: 78-30020
• Device Lot Number: 1603091006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1