MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SP2 MI FEM CHMF CUT BLK SZ 3; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	950501028
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
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 threaded pin became stuck in side hole.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint (b)(4).Investigation summary : the complaint sample consisted of (1) 950501028 sp2 mi fem chmf cut blk sz 3, lot code ae1005.The lot code indicates a vendor manufacture date of october of 2005.It was reported that the threaded pin became stuck inside the block hole.The device was returned with the alleged ¿stuck¿ pin not in the block.The pin was not returned for evaluation.Examination of the block pin holes did not find any damage.The holes were checked with a retained.125¿ fixation pin and found to pass through freely with no restrictions.The investigation could not draw any conclusions about the reported event without the pin to examine.Investigation of the returned sp2 mi fem chmf cut blk sz 3 did not find any evidence of product malfunction or product error.Based on the inability to identify product error, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2 MI FEM CHMF CUT BLK SZ 3
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8395487
• Report Number: 1818910-2019-86596
• Device Sequence Number: 420066
• Product Code: JWH
• UDI-Device Identifier: 10603295224303
• UDI-Public: 10603295224303
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/20/2019

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: 950501028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR