MAUDE Adverse Event Report: NEWDEAL SAS DRILL DIAM 1.9MM/80MM LENGTH; HALLU-FIX

Catalog Number 119618ND

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the burr does not drill.The has problems with the drill.He said the design had changed and that the distal part of the drill is not the same anymore.This drill does not work properly and especially when the bone is a little bit hard.It was reported that although the device was in contact with the patient, no patient injury is alleged.It was reported the event led to a significant increase in surgery time of 15'.

Manufacturer Narrative

Integra has completed their internal investigation on 25oct2016.The investigation activities included: methods: -review of device history records.-review of complaint history.Results: dhr for lot fe58 reviewed and no anomalies associated with the complaint were observed.This is the sixth incident for similar issue after the review complaint records during last two years.The (b)(4) items were sold during this period, drills 119618nd being single use instruments.The global rate failure is evaluated at 1.26 %.This is the second incident for lot fe58 manufactured on 8th june 2014 and (b)(4) parts were released.We have a same product of the same lot available in inventory.Visual examination showed that the drill is not sharp.Conclusion: although looking at product from inventory, the product in question was "thrown out", therefore, root cause could not be determined although we confirmed on the inventory lot that there was a problem of drill, "not being sharp".A supplier corrective action was opened and completed by the supplier.The supplier had no product in production at this time and future production has been placed on quality hold pending resolution of the issue.The investigation identified 2 root causes: a blue print misinterpretation of the mention ¿no relief on point¿ that caused confusion.The approved manufacturing method used for sterile drills was not transferred to non-sterile drills.Root cause and parts inspection confirm only non-sterile drills are affected and only 3 non-sterile lots have been manufactured since this supplier is approved.Only distribution in (b)(4) are impacted.A voluntary recall was initiated for effected lots which were determined to not be sharp enough to prepare screw holes.

• Brand Name: DRILL DIAM 1.9MM/80MM LENGTH
• Type of Device: HALLU-FIX
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5743252
• MDR Text Key: 48773021
• Report Number: 9615741-2016-00036
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dental Hygienist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119618ND
• Device Lot Number: FE58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1