MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE UNIV MEDIAL WALL PLATE/0.5MM THICK; PLATE, BONE

Model Number	04.503.305
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Customer quality investigation: the ti matrixmidface univ med wall pl/0.6 was not returned, and the investigation will be completed based on the supplied photo.The photo was reviewed, and the complaint condition was confirmed as the photo showed the most distal hole close to the edge of the plate was deformed.The medial wall plate was not returned and as received, dimensional, and material review were not applicable.Manufacturing record evaluation a manufacturing record evaluation could not be performed as the lot number could not be determined from the provided image.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/ manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during a procedure the plate had a hole in poor condition.There was no surgical delay.The procedure was completed successfully.This report involves one (1) ti matrixmidface univ medial wall plate/0.5mm thick.This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXMIDFACE UNIV MEDIAL WALL PLATE/0.5MM THICK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11648433
• Report Number: 8030965-2021-02785
• Device Sequence Number: 14366888
• Product Code: JEY
• UDI-Device Identifier: 10887587019604
• UDI-Public: (01)10887587019604
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K050608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 04.503.305
• Device Catalogue Number: 04.503.305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Patient Sequence Number: 1