MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X380 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18470938S

Device Problems Off-Label Use (1494); Difficult to Remove (1528)

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

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The sales representative reported that the surgeon was unable to get the nail off the jig and that the nail holding screw was locked into the nail.The surgeon had to remove the nail from the patient and reinsert a new one.The nail was difficult to remove and the overall process took approximately an additional 2 hours, bringing the total duration of the procedure to between 4 and 5 hours.During the process of removing the nail the customer used and damaged a variety of devices including two t handles, 1 extraction rod and 1 long screwdriver, which were not used for their primary purpose.The nail had to be removed and another nail implanted.This resulted in a 2 hour surgical delay.

Manufacturer Narrative

Examination of return product revealed no deficiency.Item did not contribute to event.Thus, concomitant item.

Event Description

The sales representative reported that the surgeon was unable to get the nail off the jig and that the nail holding screw was locked into the nail.The surgeon had to remove the nail from the patient and reinsert a new one.The nail was difficult to remove and the overall process took approximately an additional 2 hours, bringing the total duration of the procedure to between 4 and 5 hours.During the process of removing the nail the customer used and damaged a variety of devices including two t handles, 1 extraction rod and 1 long screwdriver, which were not used for their primary purpose.The nail had to be removed and another nail implanted.This resulted in a 2 hour surgical delay.

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X380 MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 5955504
• MDR Text Key: 55245274
• Report Number: 0009610622-2016-00428
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K032898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 18470938S
• Device Lot Number: K0CF7C4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other