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

Catalog Number 228730000

Device Problem Fitting Problem (2183)

Patient Problem Not Applicable (3189)

Event Date 06/06/2018

Event Type  malfunction  

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 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.

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
• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7645094
• MDR Text Key: 112564033
• Report Number: 1818910-2018-63365
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295110033
• UDI-Public: 10603295110033
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228730000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1