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

Catalog Number 18061401

Device Problems Improper or Incorrect Procedure or Method (2017); Fitting Problem (2183)

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

Event Date 10/05/2014

Event Type  malfunction  

Event Description

The sales rep, (who was present during the procedure), has reported on behalf of the customer, that when it came to attaching a tibial nail onto the spi nail adaptor the spi nail holding screws would reportedly not fit through the nail adaptor.The sales rep has reported that this resulted in the scrub team/ surgeon being unable to attach the nail onto the adaptor.The sales rep has reported that this meant, having made an incision through the quadriceps tendon, there was no way of getting the nail down the tissue sleeves with the jig attached for guided proximal locking.The sales rep has reported that an approximate delay of 30 mins to surgery occurred while the surgeon was trying to fix the jig and get the nail holding screw through and then finding alternative ways of getting the nail down the shaft of the tibia.The sales rep has reported that she suggested using the t2 universal rod and the surgeon locked proximally with 1 screw freehand.The sales rep has reported that the surgeon would have placed two screws proximally through the jig if he were able to have attached the nail to the jig.The sales rep has reported that the patient was a (b)(6) year old male.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.To add to this complaint, the sales rep has also reported that these instruments were from a newly commissioned demo loan kit set ((b)(4)).On friday (b)(6), the sales rep was at the account performing a "show and tell" demonstration of the instrumentation that went on to be used on (b)(6).The sales rep has reported that she had ordered the customer a live loan set to use in surgery, which was delivered to the customer.The sales rep has reported that she then took the live kit to sterile services so that it would be ready to sterilize.The sales rep is unaware how the demo set went on to be used instead of the live kit, and that the surgeon believes this to be a hospital error.As mentioned previously, the demo set was newly commissioned and has never been used on saw bones or cadavers and had only been used as part of the show and tell demonstration.The sales rep has reported that all instrumentation from the demo kit was sterilized prior to use in surgery.The sales rep has reported that it was noted after surgery that the demo kit was appropriately labeled with "demo" labels.

Manufacturer Narrative

Evaluation summary: a review of the dhr revealed no discrepancies.Evaluation did not reveal any discrepancies in material or manufacturing of the returned devices.The appearance of damage indicates that the devices got jammed by ¿cold welding¿ due to friction welding being caused by high surface pressure.Local surface pressure may arise when the items are assembled under misalignment which cannot be excluded during training.A deficiency in the undamaged areas of the returned items was not verified.The products had left the manufacturing site in intended condition.

Event Description

The sales rep, (who was present during the procedure), has reported on behalf of the customer, that when it came to attaching a tibial nail onto the spi nail adaptor the spi nail holding screws would reportedly not fit through the nail adaptor.The sales rep has reported that this resulted in the scrub team/ surgeon being unable to attach the nail onto the adaptor.The sales rep has reported that this meant, having made an incision through the quadriceps tendon, there was no way of getting the nail down the tissue sleeves with the jig attached for guided proximal locking.The sales rep has reported that an approximate delay of 30mins to surgery occurred while the surgeon was trying to fix the jig and get the nail holding screw through and then finding alternative ways of getting the nail down the shaft of the tibia.The sales rep has reported that she suggested using the t2 universal rod and the surgeon locked proximally with 1 screw freehand.The sales rep has reported that the surgeon would have placed two screws proximally through the jig if he were able to have attached the nail to the jig.The sales rep has reported that the patient was a (b)(6) old male.

• Brand Name: NAIL HOLDING SCREW 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-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4216126
• MDR Text Key: 4972418
• Report Number: 0009610622-2014-00608
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131365
• 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: 10/05/2014

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: 18061401
• Device Lot Number: K07E94B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 10/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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