MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 18MM FOR IM NAILS; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.005.408

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2019.Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 (b)(6) reports an event as follows: it was reported that patient was scheduled for a multiloc implantation on an unknown date.Instead of receiving two modules of multiloc implants and instruments, the client received the instrument module multiloc and the pin han screws.The surgery had originally been planned as a minimally evasive clamping surgery and with the patient anesthetized, the surgeon had to change the procedure to a large extension approach with osteosynthesis with philos plate.The surgery was more time consuming and more traumatic by the extension of the incision.Procedure was completed successfully with a two (2) hour delay.Patient is recovering without problem.This report is for a 4.0mm titanium (ti) locking screw.This is report 2 of 3 for (b)(4).

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 18MM FOR IM NAILS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8874033
• MDR Text Key: 153683301
• Report Number: 8030965-2019-67003
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819759855
• UDI-Public: (01)07611819759855
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention