MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNULATED TAP F/7.0MM CANN SCREWS 230MM/150MM CALIBRATION; TAP, BONE

Catalog Number 311.690

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.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 (b)(4) reports an event as follows: it was reported that during a tibial hemi-epiphysiodesis procedure on (b)(6) 2019, the cannulated tap broke in the patient's bone during normal used.It was noted three (3) centimeters of the device were retained in the patient.The surgeon used another screw via another route without tapping to successfully complete the procedure.There was a ten (10) minute delay reported.The patient outcome was reported as very well.This report is for a cannulated tap.This is report 1 of 1 for (b)(4).

Event Description

It was reported that during an external right tibial hemi-epiphysiodesis procedure for a treatment of a limb length inequality on (b)(6) 2019, the cannulated tap was broken in the patient's bone during its normal used.A 3cm broken fragment retained on the patient.The procedure was successfully completed using another screw via another route without tapping.There was 10 minutes surgical delay reported.Patient status and was good.It was mentioned that the tap will be left in place and will not cause discomfort in any way, nor for the growth and will cause no pain.

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.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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in 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.

• Brand Name: CANNULATED TAP F/7.0MM CANN SCREWS 230MM/150MM CALIBRATION
• Type of Device: TAP, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8605413
• MDR Text Key: 145505002
• Report Number: 8030965-2019-63881
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819019447
• UDI-Public: (01)07611819019447
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.690
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR