MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ADV PERIPHERAL DRILL GUIDE; DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES

Catalog Number	212861008
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no products were returned for investigation.However, we did receive an initial investigation report from (b)(6) that had photographs of the three products that confirmed the drill product was dull and showed signs of excessive wear.The complaint was found to be unjustified.The reason that the drill could not drill was down to excessive wear and tear.The ifu does state that the products should be visually checked prior to use for wear.No corrective action is required.Addendum added 02-september-19.Following receipt of the complaint products, the products were inspected and general wear of the drill bit was confirmed.It was concluded that: based on the information received and the investigation performed, the most likely cause of the complaint is instrument dulling over time from repeated use.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon recognized that the frill tip was dull because the surgeon could not perform drilling (with drill guide (p/n and lot number were unknown)) to open the bone hole to implant the glenoid component into the patient¿s body during tsa surgery on (b)(6) 2019.The surgeon tried to open the bone hole without drill guide, however, the surgeon could not open the bone hole again.The surgery was completed by using alternative drill tip (p/n and lot number were unknown).There was less than 30mi.Surgical delay and no harm to the patient.No further information was provided by the hospital.

• Brand Name: GLO ADV PERIPHERAL DRILL GUIDE
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9207613
• Report Number: 1818910-2019-110633
• Device Sequence Number: 449477
• Product Code: HWT
• UDI-Device Identifier: 10603295089308
• UDI-Public: 10603295089308
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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 Catalogue Number: 212861008
• Device Lot Number: AK0905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1