MAUDE Adverse Event Report: SYNTHES HAGENDORF ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL; PLIERS, SURGICAL

Catalog Number 03.607.009

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Udi: (b)(4).Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter's telephone: (b)(6).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 (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6)2017, the rod introduction pliers broke.All fragments were retrieved.Surgery was completed successfully with a delay of approximately one (1) hour.No patient harm was reported.Concomitant devices reported: wire (part number unknown, lot number unknown, quantity 1).This report is for one (1) rod introduction pliers for uss polyaxial.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 3.607.009, lot# 8929293.Manufacturing location: (b)(4), manufacturing date: may 22, 2014.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing evaluation was completed.The visual inspection shows that the device is in a used condition and visible damages and deformations were observed.The review of the production history revealed that this uss-ii polyaxial rod instruction pliers was manufactured in may 2014 per the specifications.No manufacturing related issue that would have contributed to this complaint were found.The device has been tested with the functional gages.During opening and closing unsmooth running was observed because of the damages and deformation of the plier.This damages and unsmooth running of the plier has no impact on important product functionality.No production failure has been found.This complaint is not confirmed.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

Date received by manufacturer was inadvertently reported as aug 18, 2017 in mw-459601.The correct date is sep 12, 2017.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: ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6754919
• MDR Text Key: 81609899
• Report Number: 3003875359-2017-10374
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.607.009
• Device Lot Number: 8929293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2014
• 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