MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM; BONE PLATE

Catalog Number 401.956

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.(b)(4).Lot unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Facility full name: (b)(6) hospital.Facility address not available for reporting.Initial reporter is (b)(4) consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported during a procedure for a jaw deformity on (b)(6) 2017, surgeon had inserted and removed the screw several times to obtain temporary fixation of the lock-plate.After inserting and removing several times, the screw and the plate were fixed by the locking mechanism and could not be removed.Surgery was completed successfully with an unspecified delay.No adverse consequence to the patient was reported.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7179063
• MDR Text Key: 97405273
• Report Number: 8030965-2018-50225
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819772724
• UDI-Public: (01)07611819772724(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1