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

Catalog Number 03.505.004

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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 this is report 2 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Additional common device name: dzj.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.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

Additional narrative: additional manufacturing date: march 22, 2013.A review of the device history records was completed: synthes (b)(4) manufactured the handle for 90° screwdriver, part 03.505.004, and lot 8122253.A non-conformance report was issued for product missing barcode label on package.The lot was re-inspected 100% and 1 piece reworked to place the label; the non-conformance report was closed.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: 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

Upon inspection of returned device, it was noted that three additional parts were returned that were connected to the driver shafts.This is report 2 of 7 for (b)(4).

Manufacturer Narrative

An updated device history record review was completed: review from monument for the time after the part was shipped from synthes (b)(4): dhr 03.505.004 - handle for 90° screwdriver - lot 8122253: synthes (b)(4) manufactured the part.A non-conformance report was issued for product missing barcode label on package.The lot was re-inspected 100% and one piece reworked to place the label.The non-conformance report was closed.Review of the device history record 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

A manufacturing evaluation was completed: no visible damage.The device was produced and distributed in september 2012.All items are in perfect working order.No visible damage.Unfortunately we were not able to reproduce the complained issue.The device works like per design intended when mounted as foreseen.Therefore it is likely that the instrument works correctly when distributed.No further investigation needed because no product fault could be detected.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: HANDLE FOR 90° SCREWDRIVER
• 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: 4016390
• MDR Text Key: 4710116
• Report Number: 2520274-2014-13176
• 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,Followup,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.004
• Device Lot Number: 8122253
• 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: 01/21/2013
• 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