MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS 7IN 9MM ROD; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	228730000
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Tka surgery was performed on (b)(6) 2018.During the surgery, the surgeon installed ap cutting guide med after size measurement to the patient¿s knee joint, and drilling was performed normally using the im initiator drill for the tibia.Then, when the surgeon tried to mount the rod to the guide, it was reported that femoral im alignment rod could not be mounted to the cutting guide because the holes could not fit.The surgery was completed by hammering the alignment rod into the cutting guide with a hammer.After surgery, the surgeon checked the instrument¿s condition, and found that it was difficult to detach it by hand.There was less than 30 min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
(b)(4) examination of the returned device confirmed the reported event.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: LCS 7IN 9MM ROD
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7645094
• Report Number: 1818910-2018-63365
• Device Sequence Number: 19068937
• Product Code: HWT
• UDI-Device Identifier: 10603295110033
• UDI-Public: 10603295110033
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: 228730000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1