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

Catalog Number 352.040

Device Problems Fitting Problem (2183); Connection Problem (2900)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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

It was reported that the connecting device for a flexible reamer would not connect to the shaft during a surgical procedure on (b)(6) 2015.As a result, the device came loose whenever the surgeon attempted to ream the intramedullary canal of the patient's femur.There were no fragments generated or surgical delays noted.The procedure was completed successfully with another flexible reamer and reamer shaft.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and device history records was conducted.The report indicates that the: manufacturing location: (b)(4), part #352.040, lot #2087822 manufacturing date: february 2th 2004, no anomalies were detected during device history record review.No ncrs were generated during production.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.An investigation summary was performed.The investigation of the complaint articles has shown that:it was reported that a flexible shaft connector for use with jacobs chuck (351.16j lot 4738173 mfg 14apr2004) would not fully connect to a 5.0mm flexible shaft (352.040 lot 2087822 02feb2004); the result of which was the shaft coming loose during reaming of a femoral intramedullary canal.No fragments or surgical delay were reported and the procedure was successfully completed with alternate instruments.The returned devices were examined and the complaint condition was able to be replicated as the flexible shaft was not retained by the flexible shaft connector.A root cause related to incorrect assembly of the connector was determined after disassembling the device.This investigation summary is approved.Lot number was identified upon receipt of subject device and added.Synthes manufacturing location was discovered upon receipt of subject device.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 PA 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: 5298442
• MDR Text Key: 33534729
• Report Number: 2520274-2015-17897
• 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
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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: 2087822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 72 YR