MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 35; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 2274-35-500

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After the conference, the following divergences were detected: defective product.The damage is unspecified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned, but a photo was provided confirming the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 35
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11914096
• MDR Text Key: 256244570
• Report Number: 1818910-2021-11459
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109174
• UDI-Public: 10603295109174
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/06/2021

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 Model Number: 2274-35-500
• Device Catalogue Number: 227435500
• Device Lot Number: PG263519
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1