MAUDE Adverse Event Report: SYNTHES BETTLACH 3.2MM THREE-FLUTED DRILL BIT QC/210MM/68MM CALIBRATION; BIT, DRILL

Catalog Number 315.330

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

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4).The surgery was prolonged by 45 minutes as a result of the malfunction, and it was not possible to insert a second screw.It was reported that a fragment from the drill bit remained in the patient.Subject device has not been received.Without a lot number, the device history record review and 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.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that during surgery, the drill bit broke during wicking of the distal locking.A drill bit of smaller length would have been more appropriate to minimize the risk.The surgery was prolonged about 45 mins.There was no possibility of inserting a second anteroiorposterior screw.A broken off fragment of the wick was left in the patient.The intervention was completed by a single distal locking instead of the double anteroposterior expected.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: 315.330 / 2051073 manufacturing location: (b)(4), manufacturing date: 18.March 2003.No anomalies were detected during device history record review.No ncrs were generated during production.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.Synthes manufacturing location was discovered upon receipt of subject device.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 product investigation was completed: the drill bit is broken at the end of the flute.The broken part is missing.Our investigation shows that the drill bit in question is indeed broken as mentioned in the complaint description.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the received information and without all involved parts/fragments we cannot determine the exact root cause.Due to the wear and tear signs and the age of the device, produced in 2003, it is likely that the cause of the breakage is the result of a mechanical overload situation during use.The bad condition of the device, before surgery, may also have played a contributory negligence to the breakage.The microscopic view of the broken surface shows a homogenous surface what indicates material conformity.Because of the damage and the missing part, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.No product fault could be detected.Per dhr review of the known lot numbers were the parts manufactured according to the specification.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: 3.2MM THREE-FLUTED DRILL BIT QC/210MM/68MM CALIBRATION
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5806808
• MDR Text Key: 49944633
• Report Number: 2520274-2016-13527
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315.330
• Device Lot Number: 2051073
• Other Device ID Number: (01)07611819020184 (10)2051073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2003
• 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
• Patient Age: 66 YR