MAUDE Adverse Event Report: SYNTHES USA REDUCTION FORCEPS WITH POINTS RATCHET 200MM

Catalog Number 399.980

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.No patient name or identifier reported.Date of event: unknown.(b)(4) lot unknown.Device is an instrument and is not implanted/explanted.Device is not expected to return.Telephone number not reported for the reporter.(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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows it was reported that during a sternal closure following a coronary artery bypass surgery on an unknown date, the sternal reduction forceps caused a bleed in the intercostal vessels when using them to reduce the sternal halves.This was noted after the zipfix had been applied peristernally, and the cut ends of the zipfix implants.The implants were already passed through the locking head.Therefore, the zipfix had to be cut out for removal and after the intercostal vessel bleed was sutured, more zipfix was used to close the sternum.To complete the surgery, wires were used to close the sternum instead of the sternal reduction forceps.A 20 minute delay in surgery was noted.Patient status is unknown.Concomitant parts reported: sternal zipfix (part# 08.501.001.05s, lot# unk, qty 1).Sternal zipfix (part# 08.501.001.01s, lot# unk, qty 2).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Event was an adverse event with which required medical intervention.A product problem was not alleged.The subject device is not expected to be returned to the manufacturer for evaluation as no product problem was alleged.(b)(6).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: REDUCTION FORCEPS WITH POINTS RATCHET 200MM
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5983304
• MDR Text Key: 55813194
• Report Number: 2520274-2016-14721
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: STERNAL ZIPFIX (PART# 08.501.001.01S, LOT# UNK, 2; STERNAL ZIPFIX (PART# 08.501.001.05S, LOT# UNK, 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 150