MAUDE Adverse Event Report: SYNTHES BETTLACH 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM; BIT, DRILL

Catalog Number 323.062

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is pending completion.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent an implant procedure of a variable angle distal humerus plate to treat a distal humeral fracture.During the procedure, the tip of a drill bit broke as the surgeon overly flexed the patient's upper arm.The surgeon attempted to confirm the depth of the drill bit under image intensifier at the time of drilling.The breakage occurred on the plating of the medial side after lateral plating had been completed.All fragments were retrieved.The procedure was completed successfully with a sixty (60) minute extension.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records was conducted.The report indicates that the 323.062 / lot 9306863, manufacturing location: (b)(4), manufacturing date: 07.Jan.2015, 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.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.A manufacturing investigation was performed for the subject device (2.0mm drill bit with depth mark/qc/140mm, part number 323.062, lot number 9306863).The measured hardness of the drill bit was 52,7 hrc which is within the specifications (52 -0/+3 hrc).The measured diameter of the shaft 1.98mm also met the specification (2.0 0/-0.0mm).The previously reported review of the device history records also showed that the subject device lot was released after passing final inspection.Based on the investigation no manufacturing related-issues were identified which would have contributed to the complained event.The complained condition was confirmed.In conclusion a mechanical overloading during use as most probably root cause for the breakage.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5200635
• MDR Text Key: 30362532
• Report Number: 9612488-2015-10544
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 10/21/2015

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: Health Professional
• Device Catalogue Number: 323.062
• Device Lot Number: 9306863
• Other Device ID Number: (01)07611819166264(10)9306863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2015; 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• 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: 79 YR