MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.6MM DRILL TIP GUIDE WIRE 200MM; PIN,FIXATION,SMOOTH

Catalog Number 02.113.001

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); Foreign Body In Patient (2687)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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: on monday, august 26, an osteosynthesis of tibial plates with proximal tibial system was performed in the (b)(6).During the procedure when removing 1.6 pin (ref 02.113.001) from the temporary clamping of the plate, one pin fractures remaining inside the patient.The surgery is completed successfully.The pin was marked on the equipment.Concomitant device/s reported: unknown plate (part#: unknown, lot#: unknown, quantity#: 1).Unknown clamp (part#; unknown, lot#: unknown, quantity#: 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient code 2645 has been updated to 2687.Device code 2907 has been updated to 1069.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: 1.6MM DRILL TIP GUIDE WIRE 200MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9106820
• MDR Text Key: 159849785
• Report Number: 8030965-2019-68567
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819348615
• UDI-Public: (01)07611819348615
• Combination Product (y/n): N
• PMA/PMN Number: K080943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.113.001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2019
• Patient Sequence Number: 1
• Treatment: UNK - PLATES.; UNK - PLATES.; UNKNOWN CLAMP.; UNKNOWN CLAMP.