MAUDE Adverse Event Report: SYNTHES SELZACH Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED

Catalog Number 03.505.075

Device Problem Break (1069)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the drill bit was broken during surgery.There was no patient harm.There was a surgical delay of thirty minutes reported.This report is 1 of 1 from complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A device history review was conducted.The report indicates that no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Subject device has been received and is currently in the evaluation process.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

Device was used for treatment, not diagnosis.Additional narrative: the visual inspection of the returned device performed as part of the manufacturing investigation reported the tip of the drill bit is broken.The investigation cannot confirm exactly what happened, the complaint condition is likely the result of the application of excess mechanical force resulted in this damage or the drill bit could have come in contact with hard surface (bone or metal).This drill bit was manufactured to specification and met all release criteria in march 2012.We would like to point out that this drill bit due to its design and size needs to be handled with care.No actual product fault could be found with this article.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4051366
• MDR Text Key: 18867441
• Report Number: 2520274-2014-13374
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.075
• Device Lot Number: F-13296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 09/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2014; 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• 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