MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SIGMA HP FBT KEEL PUNCH IMPACT; KNEE INSTRUMENT : HANDLES

Model Number	9505-02-055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional 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.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.The investigation could not verify or identify any product contribution to the current reported event without the device to examine.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 based on the inability to confirm the reported event or draw any conclusions about root cause, the need for corrective action was not indicated.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.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 or Problem Description
It was reported that the handle was broken.There was no surgical delay.

• Brand Name: SIGMA HP FBT KEEL PUNCH IMPACT
• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 15916638
• Report Number: 1818910-2022-24343
• Device Sequence Number: 20009125
• Product Code: HWA
• UDI-Device Identifier: 10603295227717
• UDI-Public: 10603295227717
• Combination Product (Y/N): N
• Initial Reporter Country: BD
• 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
• Report Date (Section B): 12/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: 9505-02-055
• Device Catalogue Number: 950502055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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