MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP PIN IMPACTOR/EXTRACTOR; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Catalog Number	950502070
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 clip in the mid of the instrument does not hold any longer.This was seen in cssd.No surgery delay, no adverse consequences for anybody.
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.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 # pc-(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.Reopen due to receipt of complaint device.Update (b)(4) 2018 examination of the returned device confirmed the reported event of inability to retain a mating pin.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative

• Brand Name: HP PIN IMPACTOR/EXTRACTOR
• Common Device Name: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7490242
• Report Number: 1818910-2018-58984
• Device Sequence Number: 11181865
• Product Code: LXH
• UDI-Device Identifier: 10603295227861
• UDI-Public: 10603295227861
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/11/2018

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: No Information
• Device Catalogue Number: 950502070
• Device Lot Number: J0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 10/23/2018; 10/26/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 09/12/2018; 10/31/2018; 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1