MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP TIBIAL TRAY HANDLE; KNEE INSTRUMENT : HANDLES

Model Number	9505-02-028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Surgeon was removing tibial tray with inserter.Inserter pegs broke off of the sigma hp inserter handle.Tray was damaged as well was surgery delayed due to the reported event? no, was procedure successfully completed? yes, were fragments generated? yes, if yes, were they removed easily without additional intervention? yes, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study, unknown, ip-00900914 device property of none, device in possession of none, ip-00900915 device property of none, device in possession of none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned.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.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received stated that the holes for connecting the inserter were bent and warped.All broken pieces were retrieved.

• Brand Name: HP TIBIAL TRAY HANDLE
• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10166047
• Report Number: 1818910-2020-14050
• Device Sequence Number: 3637113
• Product Code: LXH
• UDI-Device Identifier: 10603295227489
• UDI-Public: 10603295227489
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2020

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: 9505-02-028
• Device Catalogue Number: 950502028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/19/2020; 07/21/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 06/24/2020; 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1