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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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.

Event Description

It was reported that a synthes sales consultant received the following instruments with issues from field inventory: forceps for broken screw removal with spring handle broken into two pieces and; two 5.0mm flexible shafts that will not allow the guide wires to pass through them when attached to the reamer head.There was no report of patient, surgical or facility involvement.It is unknown when the complaint issues occurred.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned flexible shafts were examined and found to be without identifiable defect or deficiency.As the reaming head and guide wire utilized in the procedure were not returned the complaint condition is not able to be replicated.The complaint is unconfirmed.The returned devices were examined and the complaint condition was unable to be confirmed as the mating instruments were not returned.There were no identifiable defects or deficiencies with the returned shafts.A 2.5mm gage pin was utilized to simulate the shaft diameter of the applicable reaming rod and in each instance it was able to successfully pass through the shaft.The flexible reamer technique guide notes that the smooth end of the 2.5mm reaming rod must be inserted into the reamer head until the ball touches the head.It is possible that the surgeon was attempting to insert the ball end of the reaming rod which has a diameter which exceeds the shaft inner diameter and would therefore not pass through.Relevant drawings for the returned instruments were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No non-conformance reports 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.The complaint condition was unable to be replicated, so such no root cause was able to be determined.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 5324826
• MDR Text Key: 34302165
• Report Number: 9612488-2015-10653
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• 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: 2260145
• Other Device ID Number: (01)10886982194114(10)2260145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2007
• 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