MAUDE Adverse Event Report: NEWDEAL SAS DIAM 4.3MM SHORT DRILL; N/A

Catalog Number 119139ND

Device Problems Break (1069); Entrapment of Device (1212); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that during an austin vs mcbride vs lapidus procedure, the device broke in patient's foot.Surgeon used one qwix screw and was going to use another when the drill bit broke.Surgeon took an x-ray and decided to leave it implanted due to not being able to get it out and thought it would be fine.He closed up after this with sutures.

Manufacturer Narrative

Integra has completed their internal investigation on january 16, 2017.The investigation included: methods: review of device history records; review of complaints history.Results: dhr review; dhr unable to be reviewed as lot number was unavailable.Complaints history; the lot number is unavailable, so we cannot determine the lot rate failure.Conclusion: the root cause cannot be determined as the product was not returned.

Manufacturer Narrative

Integra has completed their internal investigation on february 7, 2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; evaluation verified complaint as valid.Drill broke at the level of the countersink cutting lips of the drill.An inspection is done following incoming inspection instruction for pn 119139nd.All the results are in compliance with specifications except the diameter of the broken bit which cannot be measured.Dhr review; dhr for lot fcnp reviewed and no anomalies associated with the complaint were observed.Complaints history; a review of the complaint system was performed.This is the second incident reported about a breakage during use of qwix 4.3mm drill pn 119139nd (for the past two years).P/n 119139 is a single use device.During the same time period, about (b)(4) qwix 4.3mm drills, pn 119139nd have been sold.The complaint rate for this kind of incident during the stated time period is (b)(4) percent.This is the first incident for the lot fncp.(b)(4) items were released, so the lot failure is (b)(4).Conclusion: given the description of the event and the observations during documentation review and on the device returned, the root cause of the breakage cannot be determined.No anomaly was found during product analysis and documentary review including review of manufacturing file, technical specifications and quality records.The short drill diameter 2.6 mm is a single use device not intended to be reused.Reusing of the short drill could explain the breakage of the short drill 119139.

• Brand Name: DIAM 4.3MM SHORT DRILL
• Type of Device: N/A
• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6234332
• MDR Text Key: 64611664
• Report Number: 9615741-2017-00001
• 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
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119139ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2017; 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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