MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER T2 TIBIA SPI ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1806-1402

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that during a case using a t2 tibial nail the nail holding screw [pn 1806-1401] was jammed in the nail adaptor [pn 1806-1402]. We switched from suprapatellar to infrapatellar. A second incision has to be made and 20min delay in surgical time.

• Brand Name: NAIL ADAPTER T2 TIBIA SPI
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12613890
• MDR Text Key: 275853944
• Report Number: 0009610622-2021-00755
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327005387
• UDI-Public: 07613327005387
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1806-1402
• Device Catalogue Number: 18061402
• Device Lot Number: K0DE5A6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/12/2021 Patient Sequence Number: 1