MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 3.8 DIMTR DR BIT 25MM; HIP INSTRUMENTS : DRILLS

Model Number 2274-56-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, the patient underwent a tha of left hip for oa.When the surgeon was drilling a hole for a screw with the drill bit in question, she noticed that the drill bit was eccentric.The surgeon stopped using the drill bit and verified that the drill bit was bent.At first, the surgeon felt a slight discomfort in the rotation of the drill bit but kept drilling and inserted the screw in question.The screw could not be inserted properly to a cup and came up from the cup.The surgeon attempted to insert the screw using a screwdriver several times, but the screw could not be inserted to the appropriate depth, and the screw head got stripped slightly, and some metal pieces were generated from the screw.Finally, the surgeon gave up inserting the screw.Although the sales rep was present during the surgery, the surgeon did not ask to the sales rep about the eccentricity of the drill bit when the surgeon noticed it, and it was impossible to notice the bend of the drill bit visually.Therefore, the sales rep could not advise the surgeon to stop using the drill bit during the surgery.After all, the surgeon used another drill bit and inserted another screw.The surgery was completed successfully within 30 minutes delay.Since this type of drill bit is usually sterilized put in its case after delivery to the hospital, this drill bit was also sterilized and used for surgery in the same manner.The sales rep and surgeon understand that a drill bit is a product that is easy to be bent during use, but this time, the surgeon did not use the drill bit at an angle that causes excessive stress to it.Since a bend of the drill bit was found after use, it is reasonable to consider that it had been bent originally.The surgeon commented as follows.Because the drill bit was bent, drilling at the optimal depth was not possible, and smooth insertion of the screw was not possible either.We would like to have good instruments delivered.The tip of the drill bit was also in a blunt shape without sharpness, and it had been scraped by use over time.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was received for investigation.Visual examination of the returned device denoted dullness on the drill flutes.Cutting surface, thus a normal wear by usage, is not as sharp as first use condition.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICKSET 3.8 DIMTR DR BIT 25MM
• Type of Device: HIP INSTRUMENTS : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15264998
• MDR Text Key: 298431775
• Report Number: 1818910-2022-16241
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109310
• UDI-Public: 10603295109310
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2274-56-000
• Device Catalogue Number: 227456000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 60 KG