MAUDE Adverse Event Report: KDITTYBO@ITS.JNJ.COM SP2 MI FEM CHMF CUT BLK SZ 4; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	950501029
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
It was reported that the 4 in 1 cutting block was used to make chamfer cuts.Medial and lateral pin holes were pre-drilled and 2 pins (smooth) were placed during sawing.Pins were vibrated forward into the patient's femur.The pins were never removed as they were believed to have come out.They were discovered after implants were cemented in place.Pins were left in the patient as they look to be secured.
Additional Manufacturer Narrative
Product complaint # : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: SP2 MI FEM CHMF CUT BLK SZ 4
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): KDITTYBO@ITS.JNJ.COM; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8212794
• Report Number: 1818910-2019-79767
• Device Sequence Number: 16641222
• Product Code: NJL
• UDI-Device Identifier: 10603295224310
• UDI-Public: 10603295224310
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: Health Professional
• Device Catalogue Number: 950501029
• Device Lot Number: SO2024394
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR