MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH MOBIS

Model Number	MOBIS
Medical Device Problem Codes	Misassembled (1398); Use of Device Problem (1670); Misassembly by Users (3133)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After several complaints about bent mobis inserters because of improper use of the device an applied practice (ap31) was added to product informations.Please find the document attached.This report was done as result of fda audit fei-no.(b)(4).
Event or Problem Description
After several complaints about bent mobis inserters because of improper use of the device an applied practice (ap31) was added to product information.

• Brand Name: MOBIS
• Common Device Name: MOBIS
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, bavaria 63755 ; GM 63755
• MDR Report Key: 8564023
• Report Number: 9615021-2019-00003
• Device Sequence Number: 243534
• Product Code: MAX
• UDI-Device Identifier: 04047844023778
• UDI-Public: 04047844023778
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: MOBIS
• Device Catalogue Number: BZ0001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1