MAUDE Adverse Event Report: SYNTHES BETTLACH 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION; BIT, DRILL

Catalog Number 324.210

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

Patient Problem Perforation (2001)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation.A device history record review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that a percutaneous drill bit broke during surgery to treat an acetabular fracture on (b)(6) 2016.The surgeon started drilling the fractured area.When he was trying to feel the touch of the contralateral bone cortex, the drill mistakenly penetrated the contralateral skin.The drill bit reached the cover cloth and broke.There was no reported surgical delay.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device history records review was completed for part # 324.210, lot # 8878853.Manufacturing location: (b)(4), manufacturing date: mar 12, 2014.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Corrected data: device available for evaluation? (other).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.No additional information has been received for these fields.The manufacturing evaluation results are as follows.Upon visual inspection of the complaint device it can be seen that the first 15 mm of the tip is broken off and twisted backwards.A device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in march 2014.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Because of the damage the relevant dimensions cannot be checked for dimensional accuracy.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6080126
• MDR Text Key: 59198614
• Report Number: 9612488-2016-10447
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 324.210
• Device Lot Number: 8878853
• Other Device ID Number: (01)07611819796973(10)8878853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• 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 Outcome(s): Required Intervention