MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PFC* FLUT TIB ROD TRL 75 X 12; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number	866875
Medical Device Problem Codes	Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	04/17/2018
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
I would like to report broken items which were sent out on an orthokit booking: orthokit booking number: (b)(4); surgery date: (b)(6) 2018; surgeon: mr.(b)(6); operation: tc3 mbt revision knee replacement; hospital: (b)(6) hospital.Instrument trays affected and item codes: module 1718 sigma femoral sleeve kit (b)(4); item code affected: (b)(4) adaptor torque wrench.The torque wrench was not fit for purpose during the operation.It did not damage the patient or implants however it did delay the operation by 5 minutes.The issue with the item is that it did not torque the stem onto the adaptor sufficiently.The outcome was fine though it must be noted.Module 1655 ¿ tc3 revision knee (b)(4); item code affected: (b)(4) pfc* flut tib rod trl 75 x 12.The 75 x 12 stem did not attach to the trial mbt tibial tray which again did was not detrimental to the patient however it did delay the operation by 5 minutes.The surgeon then opted to use a 75 x 10 stem trial instead.Please can these defect items on the orthokit sets be removed and replaced.They are not fit for purpose.
Additional Manufacturer Narrative
(b)(4).No device was received for examination, therefore the reported event could not be confirmed.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.

• Common Device Name: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7510246
• Report Number: 1818910-2018-59478
• Device Sequence Number: 1242537
• Product Code: LXH
• UDI-Device Identifier: 10603295217572
• UDI-Public: 10603295217572
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 04/17/2018

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: 866875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1