MAUDE Adverse Event Report: SYNTHES TUTTLINGEN DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM

Catalog Number 03.605.002

Device Problems Device Inoperable (1663); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: june 12, 2014.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material, which was delivered as lot 27133839, is corresponding to the specifications.The hardness was measured at the time of the manufacturing between 46.10-48.93 hrc and was found to be good.No non-conformance reports were generated during production.Device 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: it was reported that the screw from the upper shaft of a disc rongeur loosened and became lost, preventing the mechanism from working.The issue occurred during the cleaning process with no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis the subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product investigation was completed: the investigation of the complaint rongeur has shown that the screw securing the upper slide is missing.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Unfortunately we are not able to determine the exact cause which has led to this occurrence.It is likely that too much mechanical force or a wrong handling has led to this damage.No product fault could be verified.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: DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5022074
• MDR Text Key: 23872985
• Report Number: 9680938-2015-10077
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.605.002
• Device Lot Number: T107441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2014
• 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