MAUDE Adverse Event Report: NEWDEAL SAS DIAM 4.3MM SHORT DRILL

Catalog Number 119139ND

Device Problems Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It was first reported the device broke while in use.The event was reported as follows: "the k-wire was placed, first use of the short drill to prepare the cortex for the screw head.After drilling, the drill was removed.The surgeon didn't see immediately that the drill was broken, so he tried to drill the rest of the screw with the long drill, but it got stuck and couldn't go any further.When he took a closer look, the part after the "screwhead drill" on the short drill was broken and still in the patient.It was completely sinked in the bone.He removed the k-wire but the broken drill piece stayed on the same place.He decided to leave it in place as a stabilizer for a second screw and to not do any further harm to the patient.After that he placed a second 4.3mm screw." although the device was in use when the event occurred, it was reported there was no patient injury.

Manufacturer Narrative

The device involved in the reported incident has been returned.The device eval is in progress.The result of the device eval will be reported in a follow up mdr submission.

Manufacturer Narrative

Integra investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: a visual inspection is performed.Drill broke at the level of the countersink cutting lips of the drill.All the results are in compliance with specifications such as internal and external diameter.In spite of the breakage, no anomaly is found.In conclusion, the product is found in compliance with specifications.A review of the device history record is performed.Lot f96n was manufactured in may 2014.No anomaly was found during this review, especially on dimensions of diameters, raw material certificate and hardness results that are in compliance within specifications.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).During the same time period, about 512 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.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.

Manufacturer Narrative

Integra has completed their internal investigation on 08/06/2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: a visual inspection is performed.Drill broke at the level of the countersink cutting lips of the drill.All the results are in compliance with specifications such as internal and external diameter.In spite of the breakage, no anomaly is found.In conclusion, the product is found in compliance with specifications.A review of the device history record is performed.Lot f96n was manufactured in may 2014.No anomaly was found during this review, especially on dimensions of diameters, raw material certificate and hardness results that are in compliance within specifications.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).During the same time period, about 512 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.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.

• Brand Name: DIAM 4.3MM SHORT DRILL
• Type of Device: NA
• Manufacturer (Section D): NEWDEAL SAS; 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: rowena bunuan ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4824509
• MDR Text Key: 5844669
• Report Number: 9615741-2015-00029
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119139ND
• Device Lot Number: F96N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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