MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18220936S

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while patient was having a t2 tibial nail inserted for fracture, the nail holding bolt went into nail adapter easily, nurse noticed surgeon struggling with attaching nail to bolt.Nail attached to jig with nail holding bolt.Nail holding bolt and nail adhered together.Nail holding bolt unable to be unscrewed from nail.T2 tibial nail 18220936s, lot k0c2702.Trocar long cat 18060215, lot k0606 was damaged in the process of trying to dis-engage nail from bolt.Nail holding bolt item 18060370 lot number not able to be visualize as it is stuck in nail adapter.Nail adapter tibia 18061002 lot khi001104.Another nail was not available on shelf; surgeon was not able to wait for a replacement item to arrive from the warehouse.Tibia reamed up from 10.5mm to 11.5mm, to accommodate nail 10mm nail (18221036s, lok456076) operating time extended an hour as a result - tibia had to be re-reamed and a screw already in situ also had to be removed.No adverse consequences to surgical outcome by going up a diameter in nail size; as specified by doctor, trocar (18060215) was damaged, second kit required and arrived in time for the trocar to be used; no delay to operating time as a result.

Manufacturer Narrative

Although repeatedly requested further product details or the products were not available.The implant and instruments were not available; therefore an inspection was not possible.The nail and nail holding screw were classified as primary products based on the event description.A review of the dhr for the nail revealed no discrepancies.Catalogue number and lot code for the nail holding screw were not available.Therefore the dhr could not be reviewed.Based on the above facts and sparse information provided the root cause of the reported event could not be determined.No discrepancies were detected during risk analysis review.The investigation of this case will be closed based on the available information.We reserve the right to re-open the investigation in case that further substantial information becomes available.

Event Description

It was reported that while patient was having a t2 tibial nail inserted for fracture, the nail holding bolt went into nail adapter easily, nurse noticed surgeon struggling with attaching nail to bolt.Nail attached to jig with nail holding bolt.Nail holding bolt and nail adhered together.Nail holding bolt unable to be unscrewed from nail.T2 tibial nail 18220936s, lot k0c2702.Trocar long cat 18060215, lot k0606 was damaged in the process of trying to dis-engage nail from bolt.Nail holding bolt item 18060370 lot number not able to be visualize as it is stuck in nail adapter.Nail adapter tibia 18061002 lot khi001104.Another nail was not available on shelf; surgeon was not able to wait for a replacement item to arrive from the warehouse.Tibia reamed up from 10.5mm to 11.5mm, to accommodate nail 10mm nail (18221036s, lok456076) operating time extended an hour as a result - tibia had to be re-reamed and a screw already in situ also had to be removed.No adverse consequences to surgical outcome by going up a diameter in nail size; as specified by dr.Trocar (18060215) was damaged, second kit required and arrived in time for the trocar to be used; no delay to operating time as a result.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM
• 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: 5475937
• MDR Text Key: 39856694
• Report Number: 0009610622-2016-00083
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K003018
• 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: 02/05/2016

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 Expiration Date: 07/31/2019
• Device Catalogue Number: 18220936S
• Device Lot Number: K0C2702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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