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

Catalog Number 03.505.004

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon experienced difficulty using the contra-angle hand piece attachments during a sagittal split ramus osteotomy (ssro) procedure on (b)(6) 2015.While drilling with the hand piece in high speed, the surgeon noted that it would work and then stop.The surgeon was able to drill while the device was working and finished the surgery without delay.During a postoperative check of the device, a rust-like, brown substance was discovered on the mortar of the inside shaft tube.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Additional product codes for this report include dzj.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

• Brand Name: HANDLE FOR 90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4747432
• MDR Text Key: 22152042
• Report Number: 2520274-2015-13585
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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