MAUDE Adverse Event Report: SYNTHES BETTLACH 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED; BIT,DRILL

Catalog Number 324.213

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part # 324.213, lot # 9944001.Manufacturing location: (b)(4), manufacturing date: may 11, 2016.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that on (b)(6) 2016, patient underwent a periprosthetic femur fracture procedure.During the procedure, a drill bit broke.The surgeon was unable to manually retrieve the fragment and the fragment remains in the patient.There was no additional medical intervention and no surgical delay.The surgery was successfully completed with another drill bit.The patient outcome was reported as stable.Concomitant device reported: drill (part# unknown, lot# unknown, quantity 1).This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6107463
• MDR Text Key: 60072411
• Report Number: 9612488-2016-10466
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 324.213
• Device Lot Number: 9944001
• Other Device ID Number: (01)10886982191274(10)9944001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2016
• 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
• Treatment: ONE (1) UNKNOWN DRILL
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR