MAUDE Adverse Event Report: SYNTHES USA ROD-INTRODUCTPLIERS F/R Ø6; PLIERS, SURGICAL

Catalog Number 388.508

Device Problem Fitting Problem (2183)

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

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.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.It was noted that the instrument sets have been used multiple times a week for many years.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 the (b)(6) as follows: it was reported that there was an issue with this is a two-part instrument involving the rod introduction pliers and additional sleeves.The sleeves were not fitting the reduction pliers; the old ones were too loose and fall off and the new ones were too tight.Multiple sets were opened to piece multiple items together to create one usable instrument.The surgery was not prolonged as the issue was noticed at the start of the procedure.This is report 9 of 9 for (b)(4).

Manufacturer Narrative

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

There was no patient harm.The procedure was successfully completed.

• Brand Name: ROD-INTRODUCTPLIERS F/R Ø6
• Type of Device: PLIERS, SURGICAL
• 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: 5886968
• MDR Text Key: 52499844
• Report Number: 2520274-2016-14215
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• 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: Reuse
• Patient Sequence Number: 1