MAUDE Adverse Event Report: SYNTHES SELZACH DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP; BIT,DRILL

Catalog Number 03.010.101

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob & weight not provided for reporting.Device is an instrument and is not implanted/explanted.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 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

Device report from synthes on an event in (b)(6) as follows: it was reported that the devices were used in the surgery for the tibial diaphysis fracture on (b)(6) 2017.The external tibial nail was used for the procedure.When the surgeon tried to place the distal locking, it was found that the (first) drill bit in was spinning very eccentrically.When another (second) drill bit was used, it was still spinning eccentrically, but less than the first drill bit; thus, the surgeon decided to use the second drill bit.Since the patient was a male, in his (b)(6), and well-built, the surgeon had a difficulty in drilling the bone.The rotation speed of the drill bit in question decreased before reaching the contralateral side of the cortex bone.Because the surgeon felt something wrong with the rotation sound of the drill bit in question, the other drill bit (quick type, 4.2mm) was used eventually and the surgery was completed successfully.The surgery was extended for 10 minutes.No adverse consequence to the patient was reported.This complaint involves 2 parts.Concomitant device: 1x unk external tibial nail.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device lot number u258635.Manufacturing location: (b)(4).Supplier: external supplier (b)(4).Manufacturing date: 20.Jan.2017.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.A manufacturing investigation was performed for the subject device (drill bit ø4.2 calibr l145 3flute w/coup, part number 03.010.101, lot number u258635).The subject device was returned to the manufacturer with the complaint condition stating: drill bit received unpacked with traces of use.Two measurements were taken ø4.2 and ø7.94.Both conformed to the valid drawing and manufacturing order.Visual inspection did show that the shaft and cutting front section do have marks of use.The plastic end piece is still in position and mounted on the shaft like it was delivered from manufacturing.Further there is some black grease adhered to this plastic piece which must be coming from the power tool used.The complained (spinning very eccentrically) could not be confirmed.Based on measurements taken, visual examination, dhr-check no manufacturing related failure could be detected and complained issue could not be confirmed.The exact root cause could not be identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP
• Type of Device: BIT,DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6976518
• MDR Text Key: 91111193
• Report Number: 3000270450-2017-10375
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775381
• UDI-Public: (01)07611819775381(10)U258635
• 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
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.101
• Device Lot Number: U258635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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 Age: 30 YR