MAUDE Adverse Event Report: NEWDEAL SAS DEPTH GAGE FOR 150 AND 200MM K-WIRES; N/A

Catalog Number 119150ND

Device Problems Bent (1059); Failure to Align (2522)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/08/2016

Event Type  malfunction  

Event Description

It was reported the received unit was bent.When you pushed a k-wire through the opening, it did not align with/against the measure, that is because the measurer was bent.It was reported the device was not in contact with the patient and no patient injury is alleged.The event did not lead to increased surgery time.

Manufacturer Narrative

Integra has completed their internal investigation on 22jul2016.The investigation activities included: methods: review of device history records.Review of complaint history.Results: device history record for lot fdm6 reviewed and no anomalies associated with the complaint were observed.(b)(4) items were released and the lot was manufactured on 18th june 2015.A review of the complaint system was performed.This is the first incident reported to newdeal about damaged large qwix® measurer for the past two years.As large qwix® measurer pn 119150nd is a reusable instrument and used at each large qwix surgery, the number of sold large qwix® screws are taken.During the same time period, (b)(4) large qwix® screws were sold.The complaint rate for this kind of incident during the stated time period is (b)(4) percent.This is the first incident for this lot.Conclusion: product not returned so evaluation unable to be performed.The investigation for cause cannot be performed.We cannot determine the root cause.As per previously reported information, no device will be returned as the distributor indicated they will use them.

Manufacturer Narrative

Additional information received on june 27th 2016 : comments from distributor: "in order to close this document regarding the depth gauge ((b)(4)) it was noticed at the office and perceived to have been bent in transit from integra to surgitech.However when the new depth gauges arrived the bend was noticed on all of them which means that this is the way it has been manufactured and that there was no damage actually in transit.We will use them as they are so you can close the document now.".

• Brand Name: DEPTH GAGE FOR 150 AND 200MM K-WIRES
• 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5755428
• MDR Text Key: 48356185
• Report Number: 9615741-2016-00044
• Device Sequence Number: 1
• Product Code: HTJ
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2016

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: 119150ND
• Device Lot Number: FDM6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2016; 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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