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 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient date of birth and weight are not available for reporting.Device is an instrument and is not implanted / explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device history records review has been requested.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 that the patient underwent an intramedullary (im) tibial nail procedure on (b)(6) 2016, to treat a tibial fracture.During the reaming process of the surgery, the quick connect jacob chuck came apart from the flexible reamer.The device was dis-assembled and a non-synthes device was used to complete the reaming process.These events resulted in a five (5) minutes surgical delay.The procedure was successfully completed.No harm was reported to the patient.The patient was reported in stable condition at the completion of procedure.This report is for one (1) flexible shaft connector for use with jacobs chuck.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: july 09, 2009.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.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

Additional narrative: concomitant devices reported: therapy date: (b)(6) 2017.Unknown flexible remer - unknown part & lot number, qty 1.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

Updated event description: 03mar2017: it was reported that the patient underwent an intramedullary (im) tibial nail procedure on (b)(6) 2017, to treat a tibial fracture.Concomitant devices reported: unknown flexible remer - unknown part & lot number, qty 1.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.The device was returned disassembled.The device was found to be missing both bars.The remaining components were able to be assembled, however, without the missing bars the device would be unable to function properly, and would lead to the complaint condition.The exact cause for the missing components is unknown, but it was likely lost while the device was disassembled in sterile processing.A visual inspection and drawing review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not able to be performed as the mating part was not returned.The flexible shaft connector (351.16j) is a component of the flexible reamer set which is utilized if reaming of the medullary canal is desired prior to the implantation of retrograde/antegrade femoral nails (r/afn), lateral femoral nails (lfn), and tibial nails (technique guide).The following drawings were reviewed during investigation.The top-level drawing ((b)(4)).The design history was not found to 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 parts were determined to be suitable for the intended use when employed.There were no issues during the manufacture of this product that would contribute to this complaint condition.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 CO CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CO CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6272403
• MDR Text Key: 65577705
• Report Number: 1719045-2017-10049
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982193742
• UDI-Public: (01)10886982193742(10)2504452
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup,Followup
• Report Date: 01/05/2017

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: 2504452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/28/2017; 03/02/2017; 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2009
• 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