MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 12/12/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a nail was inserted after a pre-surgical check.The nail was reamed up to 13.5mm and rotated manually by the surgeon for proper placement.At the time of proximal locking with the screw, the drill tip interfered with the nail.Even with a careful trial of insertion, the drill tip broke.After extracting the nail and broken drill tip, the surgeon completed another pre-surgical check during which the drill bit did not go through the nail hole because of a deformation in the nail and device.There was no loose coupling with the connecting screw.Eventually, the surgeon changed the nail size and successfully inserted the nail by reaming up to 14mm, even though there still was some interference with the nail.It was reported that the patient has hard bone.As a result, a 40 minute surgical delay was noted.This report is for one unknown drill bit.This report is 7 of 8 for (b)(4).

Manufacturer Narrative

Patient information is not available for reporting.This report is for one unknown drill bit.We were provided with a part (03.010.061) and lot (2732142), but are unsure if it belongs to this drill bit or the second one associated with this event.Device is an instrument and is not implanted/explanted.It is unknown if the complainant part will be returned to the manufacturer for review/investigation.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.

Manufacturer Narrative

Brand name of the provided catalog number is 4.2mm three-fluted drill bit qc/330mm/100mm calibration.As reported in the initial report, catalog number 03.010.061, lot 2732142 was provided by the reporter.However, it is unknown if this identifies the misaligned or the broken drill bit.A review of the device history records for this lot was performed.No nonconformance reports 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.Manufacture date of the provided lot number is may 11, 2011.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.

Manufacturer Narrative

A pd investigation was conducted.The report indicates that the drill bit is broken off at the end of the flute and the cutting edges are blunt.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 the involved parts we cannot determine the exact root cause.Due to the deformation, at the insertion handle and the nail, we can only suppose that a mechanical overload situation during use lead to the deformations.By this, a correct positioning of the nail is improbable.This occurrence could finally lead to an incorrect interaction between the drill bit and the nail which has finally lead to the breakage as result.As mentioned in the complaint description the bone of the patient is to be classified as hard which could also have played a role.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.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4411209
• MDR Text Key: 18542843
• Report Number: 2520274-2015-10295
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/06/2015; 03/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 65 YR