MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET TPRD HEX SCDR U-JOINT; SCREWCDRIVERS

Model Number 2274-63-000

Device Problems Naturally Worn (2988); Illegible Information (4050)

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

Event Date 01/01/2022

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

It was reported that the hospital spd employee brought to rep attention on 3/24/2022.Date of damage is unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this report was returned for analysis.The photo investigation and visual examination of the returned device confirmed the reported allegation, wear can be seen on the device and the base of the tip cracked.The etchings of the device can be seen and read not confirming that allegation.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.Device history lot
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> a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: QUICKSET TPRD HEX SCDR U-JOINT
• Type of Device: SCREWCDRIVERS
• 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: 14074646
• MDR Text Key: 289005300
• Report Number: 1818910-2022-06509
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109365
• UDI-Public: 10603295109365
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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: 2274-63-000
• Device Catalogue Number: 227463000
• Device Lot Number: SO2044841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• 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