MAUDE Adverse Event Report: NEWDEAL SAS K WIRE 0.8MM; K-WIRE

Catalog Number 115008SND

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 14nov2016.The investigation activities included: methods: review of complaint history.Results: unable to review dhr as lot number was unavailable.A review of the complaint system was performed.This is the fifth incident reported to newdeal about broken k-wire during last two years.During the same time period, 38111 k-wires were sold.The complaint rate for this kind of incident during the stated time period is 0.013 percent.Product returned and evaluation verified complaint as valid.The k-wire is broken inside the drill.Conclusion: we cannot determine the root cause of the incident following the investigation and the visual examination of the returned product.The k-wire broke at the end of the surgery.The breakage may result from the contact with another screw.

Event Description

This event involved 1 procedure, 1 patient, 2 devices.This is report 1 of 2.Mfr report numbers: 9615741-2016-00063.It was reported the device broke during a procedure.At the end of the surgery the k wire broke in the drill and is blocked.No impact for the patient.It happens sometimes but the care team usually manages to take off the k wire in the drill.No patient injury is alleged.The event did not lead to an increase of surgery time.

• Brand Name: K WIRE 0.8MM
• Type of Device: K-WIRE
• 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: 6124614
• MDR Text Key: 60867294
• Report Number: 9615741-2016-00062
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K022599
• 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
• Report Date: 11/02/2016

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: 115008SND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: BOLD 2,5 CANNULATED DRILL-AO "2 IN 1" L.12MM