MAUDE Adverse Event Report: SYNTHES BETTLACH FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK; REAMER

Catalog Number 351.16J

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials are: (b)(6).Patient dob, age and weight unavailable.Event date and date of this report: complaint re-open and re-assessed with additional information provided.(b)(6) 2016: investigation was completed with the following findings; the returned instrument was examined and the complaint condition was confirmed as the connector was received disassembled; all components, with the exception of both bars (2mm x 18mm), were present.The set screw utilized to retain/align the knurled cap was found to be broken upon examination.Because the investigation determined the device had a broken component.Implant and explant dates: device is an instrument and is not implanted/explanted.Date returned to manufacturer.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 03.July 2007, part# 351.16j lot# 2271117.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: a flexible shaft connector (351.16j lot 2271117 mfg 03-jul-207) became disassembled intra-operatively during a trochanteric fixation nail advanced (tfna) procedure.There were no fragments, surgical delay or patient harm.The returned instrument was examined and the complaint condition was confirmed as the connector was received disassembled; all components, with the exception of both bars (2mm x 18mm), were present.The set screw utilized to retain/align the knurled cap was found to be broken upon examination.No definitive root cause was able to be determined however the failure mode is consistent with disassembly/improper mis-assembly leading to a broken device.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot number and no mrrs, the received condition is consistent with the complaint description stating that the coupling ¿became disassembled intra-operatively¿.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Ncrs or complaint-related issues were identified with the lots number which may have contributed to the complaint condition.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 flexible shaft connector for (b)(6), quick coupling became disassembled intra operatively on (b)(6) 2015, during a trochanteric fixation nail advanced(tfna) procedure.The four inner components of the device became loose and fell out; it is likely that the inner set screw broke and is the cause.There were no reported fragments, no surgical delay, no additional x-rays or medical intervention required.The procedure was successfully completed with the patient in stable condition.This complaint involves 1 device.This report is 1 of 1 for (b)(4).

• Brand Name: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• 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: 5563078
• MDR Text Key: 42180786
• Report Number: 9612488-2016-10178
• 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
• Type of Report: Initial
• Report Date: 03/24/2016

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: 351.16J
• Device Lot Number: 2271117
• Other Device ID Number: (01)10886982193742(10) 227117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2007
• 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