MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4).Manufacturing date: 11.Apr.2008.Part# 352.040, lot# 2354615.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned, an investigation could not be performed; the review of the device history record could not be performed with an unknown lot number.Product will not be returned for further investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a trauma surgeon at (b)(6) was using the flexible reamers to ream for a tibial nail.When he would pull the reamer shaft off of the reaming rod after reaming at any diameter of reamer, the reamer heads would come off.The reamer heads did not come off of the other reamer shaft in the set.We were able to complete the case using the other reamer shaft in the set.There was no harm to the patient or delay to the surgery.This complaint involves 1 device.This report is 1 of 1 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.

Manufacturer Narrative

Unknown when device actually malfunctioned/does not/will not function - event date is (b)(6) 2016.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: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5564218
• MDR Text Key: 42218101
• Report Number: 9612488-2016-10184
• Device Sequence Number: 1
• Product Code: HTO
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 23554615
• Other Device ID Number: (01)10886982194114(10)23554615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2008
• 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
• Patient Age: 22 YR
• Patient Weight: 79