MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ACETABULAR PREP DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 9626-29-000

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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.

Event Description

Worn instruments identified by sterilisation , did not occur during surgery so no surgeon was involved.This has been reported by one of the healthcare workers at the hospital who is the contact in this form.Instruments tagged as damaged and being returned to wa operations via courier.This is a consignment set, set number tray serial / batch number is unknown.Operations please refer to the wa one drive complaint database for further information.Patient status/ outcome / consequences: no.Acetabular prep drill.Product part number.962629000.Lot# 965760.

Manufacturer Narrative

Product complaint # (b)(4) investigation summary no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing records evaluation (mre) was not performed.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specification at the time it was released for distribution.

• Brand Name: ACETABULAR PREP DRILL
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr; warsaw, IN 46580 ; 3035526892
• MDR Report Key: 15763173
• MDR Text Key: 305252578
• Report Number: 1818910-2022-22523
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295243526
• UDI-Public: 10603295243526
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 11/09/2022

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: 9626-29-000
• Device Catalogue Number: 962629000
• Device Lot Number: 965760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/1992
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1