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

Catalog Number 351.16J

Device Problems Failure To Adhere Or Bond (1031); 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.Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.S&r service history review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The service and repair department reported that the flexible shaft connector for use with jacobs chuck, adapter would not hold the reaming shaft.It kept disconnecting while the surgeon was reaming back out.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the adapter would not hold the reaming shaft.The repair technician reported the chuck pin was missing.Missing parts is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit.The evaluation was confirmed.A product investigation was completed: the instrument was received assembled and upon visual inspection of the device it appeared that one of the guide pins was missing from the connector, the complaint device was then disassembled and it was confirmed that the one of the guide pins was missing from the device preventing it from functioning as intended.The returned condition is consistent with having been disassembled.Even thou the set screw is loctite in place to prevent disassembly, it is a common practice for a device to be disassembled by force, if possible, for cleaning/reprocessing.Thus, while it cannot be definitively determined, it is most probable that disassembly for cleaning, and subsequent loss of the pins and/or improper reassembly of the device led to the complaint condition.Per the technique guide, the flexible shaft handle is part of the flexible reamer sets and used if reaming of the medullary canal is desired for implantation of retrograde/antegrade femoral nails (r/afn), lateral femoral nails (lfn), and cannulated tibial nails.A review of the current design drawing and the manufactured revision was performed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.This failure mode is typically associated with lost parts as a result of disassembly during sterilization.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.

Event Description

It was reported there was a five (5) minute delay in the procedure.

Manufacturer Narrative

Service history review: part no: 351.16j, lot no: 8053605 can be performed because the lot number is unknown and cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.Service history review: part no: 351.16j, no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 12-sep-2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• 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: 5135995
• MDR Text Key: 27807477
• Report Number: 2520274-2015-16497
• 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: Followup,Followup
• Report Date: 09/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8053605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/03/2015; 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2012
• 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: 74 YR