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

Catalog Number	217870000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
It was reported that the instrument 217870000 was purchased by account in january 2018 and used only 10-12 times.Very small screws are backing out of the instrument and are lost.Tension window adjustment does not rotate any longer.This is their 4th tensioner and the other 3 have lasted over 10-15 years.Their new one falls apart in 3 months.Product needs to be replaced or repaired.No surgical delay.
Additional Manufacturer Narrative
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 #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.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, 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: 7601256
• Report Number: 1818910-2018-62210
• Device Sequence Number: 16618801
• Product Code: HWT
• UDI-Device Identifier: 10603295096726
• UDI-Public: 10603295096726
• Combination Product (Y/N): N
• Initial Reporter State: VI
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2018

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: 217870000
• Device Lot Number: SO2024538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/06/2018; 08/22/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/30/2018; 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1