MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.928

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

Device broke intra-operatively; device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as the device was reportedly discarded.Facility phone number was not provided.(b)(4).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 that during a surgery the screw broke during insertion.The screw thread stayed in the mandible bone and the screw head stayed in the screwdriver.It was not possible remove the thread because of infectious risk.The surgery was prolonged for an unknown amount of time.No information available about patient condition and outcome.The surgeon noted that an additional surgery will be required due to the position of the broken piece, but it is unknown when that will occur.Concomitant device: screwdriver (part 314.448, lot unknown, quantity 1).(b)(4).

Manufacturer Narrative

The received x-rays confirms the complaint condition.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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• 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: 7125639
• MDR Text Key: 95172690
• Report Number: 8030965-2017-50782
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819724358
• UDI-Public: (01)07611819724358(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR