MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA K-WIRE WITH TROCAR POINT, ¿1.2, L150; INTEGRA STAINLESS STEEL HEADED COMPRESSION SCREW SYSTEM

Catalog Number 430125

Device Problem Break (1069)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 01/07/2016

Event Type  Injury  

Event Description

This is event #1 for devices from the same set: tray# headmid-007; same patient procedure, different issue.Mfr report numbers: 3004608878-2016-00029; 3004608878-2016-00030.It was reported the patient suffered tissue/bone damage due to this event.It was reported the surgeon was trying to implant a 4.0 stainless steel cannulated screw.He placed the guide wire.He proceeded to drill with the 2.5 cannulated drill bit.As the surgeon was drilling the k-wire, it broke off and the k-wire was pushed deeper inside the bone.It was impossible to recover the broken k-wire.The surgeon did attempt to recover the broken k-wire but he felt it was going to cause more damage than what it was worth.A portion of the broken k-wire was left in the patient.It was later reported the surgeon tried to get the k-wire out of the patient's bone.There was tissue damage.The surgeon stated he had to stop the attempt to retrieve the wire.There was already too much bone damage.There might need to be a revision procedure to remove the wire at a later date.It was also reported: patient injury / death alleged? no.Device in contact with patient? yes.Out of box failure? unk.Revision or medical intervention required? unk.Delay in surgery due to late receipt of product? no.Patient prepped for surgery? yes.Delay in surgery due to product problem? yes, 20-30 minutes.

Manufacturer Narrative

Integra completed its internal investigation 18aug2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: a review of the device history records determined that the k-wire (p/n 430125single, lot # qr0013) had been manufactured in late 2014 and that there were no noted material non-conformances or variances associated with the manufactured lot.A query did not find any additional customer complaints associated with a broken k-wire.The query was limited to the time frame of july 1, 2014 ¿ 2016 year to date.This is the only reported complaint in the past 24 months regarding a k-wire breaking during surgery.A review of incoming receiving records determined that (b)(4) aap midfoot screw system instrument sets have been returned to (b)(4) for inspection and replenishment from july 1, 2014 ¿ 2016 year to date.The single complaint results in a failure rate of (b)(4).Conclusion: integra was unable to conduct a complete failure analysis and identify a likely root cause.Since the k-wire was not returned, it is not possible to determine if this complaint was due to use error or from a manufacturing defect.

• Brand Name: K-WIRE WITH TROCAR POINT, ¿1.2, L150
• Type of Device: INTEGRA STAINLESS STEEL HEADED COMPRESSION SCREW SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5427952
• MDR Text Key: 38064335
• Report Number: 3004608878-2016-00029
• Device Sequence Number: 1
• Product Code: HXI
• 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,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 430125
• Device Lot Number: QR0013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Age: 46 YR