MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE TARGET DEVICE; INSTRUMENT

Catalog Number UNK_KIE

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition is unknown.

Event Description

When utilizing the ankle arthrodesis nail, 200mm, the proximal locking screws missed the nail.We had already done the lateral talus screw and swung the jig medial to do the two proximal tibia screws.Both of the proximal tibia screws missed the nail, this was a national loaner tray and targeter.The result was the surgeon took the jig off and free handed the two proximal screws.While he was doing this he mentioned looking at a postop x-ray for a previous case done that the p/a screw had missed the nail.He gave me no further information.

• Brand Name: UNKNOWN T2 ANKLE TARGET DEVICE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8075193
• MDR Text Key: 129172385
• Report Number: 0009610622-2018-01399
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other