MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP FBT NONCEM KL PNCH SZ 4-5; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET

Model Number	9505-02-051
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Scrub nurses during set up of instrument that the rubber insert inside the instrument was missing.This was noted before the surgery started.The case was completed with a like instrument.No pieces were left inside the patient.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was returned for analysis.After physical review of the part, complaint allegation is confirmed.Assembled o-ring is missing from the device.And it was not returned for examination.Also it was observed, a chipping at two of the punches.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: a manufacturing records evaluation (mre) was not performed, since a valid finished good lot number was not provided for this device.
Additional Manufacturer Narrative
The device malfunction, visual: missing components, will no longer be reported as there has not been a serious injury associated with this failure within the past 2 years.Please consider this the last manufacturer report number submitted against this malfunction.

• Brand Name: HP FBT NONCEM KL PNCH SZ 4-5
• Common Device Name: KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
• 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: 12829278
• Report Number: 1818910-2021-25433
• Device Sequence Number: 4364826
• Product Code: LRY
• UDI-Device Identifier: 10603295227670
• UDI-Public: 10603295227670
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9505-02-051
• Device Catalogue Number: 950502051
• Device Lot Number: J0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 04/26/2022; 08/25/2025
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/14/2022; 04/27/2022; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown