MAUDE Adverse Event Report: SYNTHES OBERDORF GEAR COVER FOR SCREWDRIVER 90°; DRILL, BONE, POWERED

Catalog Number 03.505.007

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 7 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

Additional manufacture date: january 29, 2013.A review of the device history records was completed: synthes (b)(4) manufactured the shaft for 90° screwdriver.The lot was received from synthes (b)(4) and released to stock.There were no material review reports, non-conformance reports, or complaint related issues with this lot.A manufacturing evaluation was completed: the device was received with no visible damage; however, the entire gear at the shaft end is missing.Our investigation shows that the entire gear at the shaft end is missing.All other items are in perfect working order.No visible damage.Based on the received information we cannot determine the exact root cause.It is likely that over tightening has led to the damage of the gear and to the malfunction of the device.Therefore the complaint relevant dimensions were checked as far as possible and find to be within specifications.We were not able to reproduce the complained issue.The device works like per design intended when mounted as foreseen.It is likely that the instrument works correctly when distributed.No further investigation needed because no product fault could be detected; the damage was clearly caused post manufacturing.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: GEAR COVER FOR SCREWDRIVER 90°
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4232146
• MDR Text Key: 4995035
• Report Number: 8030965-2014-10621
• 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: 03.505.007
• 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
• 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