MAUDE Adverse Event Report: SYNTHES SELZACH 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM-STERILE; BIT, DRILL

Catalog Number 03.010.103S

Device Problem Material Deformation (2976)

Patient Problem Sedation (2368)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.(b)(4).Lot: a lot number of 9148481 was provided, however the provided part and lot combination do not exist.Device is an instrument and is not implanted/explanted.(b)(6).Without a valid lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - part/lot combination unknown, no dhr review possible.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.

Event Description

Device report from synthes (b)(4) reports an event in the (b)(6) as follows: it was reported that the surgeon experienced resistance when advancing a reamer into the patient's femoral head.The surgeon withdrew the reamer and noticed metal debris on the reamer.When the guide wire was removed, the surgeon noticed that the guide wire had a chunk of metal on it, which prevented the advance of the reamer.There was a thirty (30) minute surgical delay reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The lot number and expiration date of the subject device was identified upon receipt.A manufacturing investigation was performed for the subject device.The investigation of the complained guide wire shows that the shaft was hit by the reamer during reaming procedure.As result of this contact, the reamer damaged the shaft what did not allow to pass the reamer as foreseen over the guide wire.This can happen, if the guide wire is bent during the procedure.The root cause of the complaint condition was due to user error during reaming.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.The device history records shows that this guide wire was according to the specification.Material 316l was used as specified.The lot was released after complete final inspection.Measuring of the outer diameter (tolerance 3.2mm 0/-0.04) results in 3.18mm what is within specified range.No non-conformances were generated during the production or sterilization of the subject device.Corrected data: manufacturing location of the device was identified and corrected.(b)(4).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/NEEDLE POINT/145MM-STERILE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5486160
• MDR Text Key: 39885974
• Report Number: 2520274-2016-11530
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.103S
• Device Lot Number: 9148481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2014
• 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: 71 YR