MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. DISPOSABLE DRILL KIT

Catalog Number	DDK2-2.4-30X
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal complaint investigation was performed for this issue.The clinical specialist was interviewed.She stated that a brand new unopened box of ddk2-2.4-30x drill bits was pulled from the cart of ad-tech supplies at the site on (b)(6) 2017.The box was intact, in good condition and sealed shut.When surgery began, the neurosurgery p.A.Opened the sealed box and pulled out one drill bit and wrench; the drill bit outer package was then opened.The surgery technician then proceeded to take the inner package out to open and place in the sterile field.Prior to opening, she examined the inner package and noticed a small hole.The outer package was then examined and a small hole was also found.They examined the box and found that the box was intact with no hole.The clinical specialist took the damaged package and box and returned the items to ad-tech on 3/2/2017.A historical complaints review was completed for the alleged deficiency "drill bit punctured pouch".There have been zero (0) similar complaints for punctured pouches between 1/1/2015 and 3/2/2017.Based on this review, no trend exists in regards to compromised sterile barriers for drill bits out in the field.A batch record review was performed on 3/29/2017 for the impacted product (lot 208140625, batch# 103107).(b)(4) drill kits were planned for this work order and (b)(4) were completed.There were no additional issues noted in the work order process notes that would contribute to the reported complaint and all kits passed the in-process and final qc checks.According to the return complaint evaluation was completed of the impacted product, the pouch packaging of the returned drill bit and stop was visually analyzed.There appeared to be penetrated punctures on the tyvek side of the inner and outer pouches.It has been concluded that the drill bit's angled tip area caused the punctures because all the penetrated and unpenetrated punctures were at reachable distance where the drill bit tip area on spiral end would have caused the punctures.The location of the penetrated punctures on the inner and outer pouches matched and appeared to have been caused at the same time.There were unpenetrated puncture marks on the clear side of the inner pouch at same location as the penetrated punctures as well as other locations.An engineering investigation was performed to attempt to reproduce the failure on two layers of pouching with another drill bit.Based on the investigation, it was found that dropping the double pouched drill bit on its tip from varying heights produced pinhole failures similar to the failure identified in the complaint.The bit was dropped from approximately 6 inches to 24 inches.This was the only method resulting in equivalent fail mode and was able to be recreated with some consistency.A reinspection of all sterile disposable drill bits in ad-tech in-stock inventory was performed on 3/7/2017.(b)(4) double pouched drill bits were inspected.No visible holes were identified on any of the (b)(4) outer pouches.To further provide evidence that this complaint was considered an isolated incident, a separate engineering investigation is currently in-process to provide objective evidence that the prospective sterile packaging configuration for ad-tech's drill kits can withstand anticipated shipping methods while maintaining sterile barrier integrity.Ad-tech is currently awaiting final results from the third party testing facility.
Event or Problem Description
On (b)(6) 2017, during a case at a customer site, the ad-tech clinical specialist witnessed a compromised sterile barrier of the packaging for one of ad-tech's sterile drill bits.Specifically, when the customer opened the box and retrieved the first drill bit pouch, a small, pin-sized hole was found on the tyvek side of the outer pouch, as well as the tyvek side of the inner pouch.The holes were identifed where the tip of the drill bit meets the pouches.Ad-tech's disposable drill kits contain 2 separately packaged drill bits per kit.There was no known patient impact and no delay in surgery.The other drill bit was not compromised and was used for the case.The impacted drill bit was sent back to ad-tech for investigation.

• Brand Name: DISPOSABLE DRILL KIT
• Common Device Name: DISPOSABLE DRILL KIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 1901 william street; racine WI 53404
• MDR Report Key: 6465561
• Report Number: 2183456-2017-00005
• Device Sequence Number: 16407497
• Product Code: HTW
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)181001(10)0103107208140625
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other