MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LIGHT SLOTTED HAMMER; KNEE INSTRUMENT : IMPACTION INSTRUMENTS

Model Number	2421-22-000
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/08/2020
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
The surgery was performed on (b)(6) 2020.It was reported that the device (p/n:242122000 or p/n: 602017000)¿s plastic top head part came off.There was no interference for the surgery and no harm to the patient.The hospital staff told that it seemed that the device¿s plastic part stripped and came off easily.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about 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.

• Brand Name: LIGHT SLOTTED HAMMER
• Common Device Name: KNEE INSTRUMENT : IMPACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10567244
• Report Number: 1818910-2020-20649
• Device Sequence Number: 11448930
• Product Code: FZY
• UDI-Device Identifier: 10603295122906
• UDI-Public: 10603295122906
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2020

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: 2421-22-000
• Device Catalogue Number: 242122000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 12/03/2020; 12/04/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 12/04/2020; 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1