MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 INDEPENDENT BALANCER; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS

Catalog Number	217870000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 4 sigma knee balancers were returned to the mto group to have spring rates measured.Upon evaluation, two of the four balancers were found to be defective.Specifically, one exhibited galling on one side of the telescoping feature and would not move freely under load.The second one appeared to have the pre-tensioned nut partially unscrewed.This eliminated the balance between the paddles.As the device is no longer available, both defective balancers were sent to the (b)(4) but neither of the devices were repairable.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: examination of the returned device found evidence of wear from normal use and servicing that contributed to the reported event.The investigation findings of device wear from normal use and servicing did not indicate that a broader investigation or corrective action was necessary.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Device has been returned, but has yet to be evaluated.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INDEPENDENT BALANCER
• Common Device Name: KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9028013
• Report Number: 1818910-2019-104350
• Device Sequence Number: 16683377
• Product Code: HWT
• UDI-Device Identifier: 10603295096726
• UDI-Public: 10603295096726
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 08/13/2019

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: 217870000
• Device Lot Number: J0806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 09/18/2019; 10/03/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/13/2019; 09/20/2019; 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1