MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVESHAFT FOR SCREWDRIVER 90°; DRILL, BONE, POWERED

Catalog Number 03.505.006

Device Problem Break (1069)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

It was reported two screwdrivers broke during surgery, the parts that broke were two handles and two shafts.The surgeon was performing a mandible fracture repair procedure and while attempting to drill a hole, the devices would not function.There was a 15 minute delay in surgery.Surgery was successfully completed with another device.Upon inspection of returned device, it was noted that three additional parts were returned that were connected to the driver shafts.This is report 5 of 7 for (b)(4).

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records 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.

Manufacturer Narrative

An updated device history record review was completed: part/lot combination unknown at synthes (b)(4).Lot 8121636 was used for the part 03.505.003, which is a screwdriver shaft.So the manufacturing documents for part 03.505.003 lot 8121636 were reviewed and no complaint related issues were found.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

Lot number 8121636 reported for the subject device corresponds to device part number 03.505.003 (shaft for 90° screwdriver).Additional information and clarification provided by synthes engineering on jan 15, 2015 revealed although this lot number corresponds to the shaft, driveshaft (subject device, part number 03.505.606) is sold in tandem with the shaft and therefore, the device history records and other evaluations for the shaft part would be relevant to the subject device driveshaft as well.Additional manufacturing date: jan 29, 2013.A review of the device history records showed there were no issues during the manufacture of the product that would contribute to this complaint condition.No anomalies were detected during device history record review and no non-conformances were generated during production.A manufacturing evaluation was performed for the returned handles, screwdriver shafts, and driveshafts.Two 90° screwdriver shafts were returned (part # 03.505.003, lot# 8121636) with the complaint that they broke during a mandible fracture repair procedure.Upon receipt of these devices it was seen that the driver shafts easily rotated and function as intended, one of these driveshafts was returned with the gear cover attached, both of these were returned with the driveshaft for 90° screwdriver (part 03.505.006, lot # 8121636 [subject device] and lot 8062742) attached.Two handles for 90° screwdrivers were returned, part 03.505.004 lot 8122253.The internal aspect of one of these was found to rotate easily and smoothly, the other is resistant to rotation.None of the returned parts were found to be broken; one of the handles however, functions at a suboptimal level.Manufacturing evaluations were performed on these devices.It was found that of these parts, one of the handles for 90° screwdrivers was found to have rough-running movable parts but no visible damage and likely was over tightened post manufacturing.All six of the remaining devices were found to be in perfect working order with no visible damage.The root cause could not be determined as none of the returned parts were found to be broken; one of the handles however, functions at a suboptimal level and likely resulted from over-tightening.For six of the parts no product fault could be detected, for the handle which sticks, this is likely the cause of over-tightening post manufacturing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVESHAFT FOR SCREWDRIVER 90°
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132 CH4
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132 CH4
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4232087
• MDR Text Key: 4975954
• Report Number: 8030965-2014-10618
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.006
• Device Lot Number: 8121636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2013
• 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: 53 YR
• Patient Weight: 52