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

Catalog Number 352.040

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that the 5.0mm flexible shaft ruptured during reaming in preparation for implantation of a nail to treat a tibial fracture.The end of the flexible shaft and the reaming head were retained in the patient¿s tibial canal and required removal.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device has been received.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.A review of the device history records for the subject device lot has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional event information was received on (b)(6) 2015.Additional patient code added.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.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.Corrected data: the complaint event was re-reviewed based on additional information received on (b)(6) 2015 and it was determined that this event is an adverse event and product problem which required intervention to prevent permanent impairment/damage.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on (b)(6) 2015 reporting that the complained event resulted in a surgical delay of 25 to 45 minutes.There was no additional patient harm.

Manufacturer Narrative

Additional narrative: a product investigation was completed: our investigation shows that the tip of the reamer is broken.Furthermore, we found that around the breakage point there is a welding seam visible.The shaft is slightly bent and shows wear and tear marks and striations on the entire instrument.The broken part is missing.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately we are not able to determine the exact cause of the breakage as not all fragments were sent back for investigation.This device was produced and distributed in june 2006.Due to the wear and tear signs and the age of the device, it is likely that this product was often and intensive used.In reference to the welded seam, which was found on the device, we can state that the manufacturing process of this part does not include any welding process step.Due this last result, we conclude, that the device was modified post manufacturing and therefore does not corresponds to our specifications anymore.Therefore the cause of failure is not due to any manufacturing non-conformances.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: 4950323
• MDR Text Key: 6635946
• Report Number: 9612488-2015-10385
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 2201847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2006
• 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 Outcome(s): Required Intervention