MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH KIRSCHNER WIRE Ø2.0X285MM; PIN, FIXATION, SMOOTH

Catalog Number 390191S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Test Result (2695)

Event Date 10/08/2014

Event Type  Injury  

Event Description

The sales rep, has reported on behalf of the customer, that whilst performing surgery with an axsos 5mm targeting device on a (b)(6) female patient (right distal shaft femoral), it was reportedly not possible to get any of the 3 locking sleeves to engage with the most proximal locking hole in the plate.The sales rep has reported that she and the scrub nurse had tested the jig with the plate for alignment in a prep room before the case had started all lined up well and the capture sleeves engaged with plate.The sales rep has reported that once the plate was inserted the surgeon could not get any of the 3 locking sleeves to engage with the most proximal locking hole in the plate.The sales rep has reported that the anesthetist advised that the patients hemoglobin was very low and therefore required a quick operation.The sales rep has reported that after a minute of trying to engage the sleeves through the tissue sleeve and the surgeon removed jig and decided to go freehand but to continue to use long instruments in the interest of time.The sales rep has reported that the surgeon could not get any of the locking sleeves to engage with 3 most proximal locking holes in the shaft and the surgeon was also using the screwdriver from the set to help him engage the sleeves in the plate.The sales rep reported that at this point the surgeon was still going via stab incisions.The sales rep reported that the surgeon ended up opening an axsos 5mm classic but by this point none of these sleeves would engage with the locking holes in the plate.The sales rep has reported that the surgeon then made the decision to drill free hand which subsequently meant none of the screws would sit flush in the plate even though the correct method of start by hand, in by power, finish by hand were used.The sales rep has reported that there was a delay to surgery of 30 minutes and that no medical intervention was required.The sales rep has reported that the patient underwent a blood transfusion prior to surgery.Post op x-ray attached in communication log.

Manufacturer Narrative

The device will not be returned.Additional information was requested and if received will be provided on a supplemental report.Device will not be returned.

Manufacturer Narrative

Evaluation summary: the received information was evaluated and there was no indication found that the device contributed to reported fitting problems between the plate and the sleeves.Therefore the device was classified as concomitant product.

Event Description

The sales rep, has reported on behalf of the customer, that whilst performing surgery with an axsos 5mm targeting device on a (b)(6) female patient (right distal shaft femoral ), it was reportedly not possible to get any of the 3 locking sleeves to engage with the most proximal locking hole in the plate.The sales rep has reported that she and the scrub nurse had tested the jig with the plate for alignment in a prep room before the case had started all lined up well and the capture sleeves engaged with plate.The sales rep has reported that once the plate was inserted the surgeon could not get any of the 3 locking sleeves to engage with the most proximal locking hole in the plate.The sales rep has reported that the anesthetist advised that the patients hemoglobin was very low and therefore required a quick operation.The sales rep has reported that after a minute of trying to engage the sleeves through the tissue sleeve and the surgeon removed jig and decided to go freehand but to continue to use long instruments in the interest of time.The sales rep has reported that the surgeon could not get any of the locking sleeves to engage with 3 most proximal locking holes in the shaft and the surgeon was also using the screwdriver from the set to help him engage the sleeves in the plate.The sales rep reported that at this point the surgeon was still going via stab incisions.The sales rep reported that the surgeon ended up opening an axsos 5mm classic but by this point none of these sleeves would engage with the locking holes in the plate.The sales rep has reported that the surgeon then made the decision to drill free hand which subsequently meant none of the screws would sit flush in the plate even though the correct method of start by hand, in by power, finish by hand were used.The sales rep has reported that there was a delay to surgery of 30 minutes and that no medical intervention was required.The sales rep has reported that the patient underwent a blood transfusion prior to surgery.Post op x-ray attached in communication log.

• Brand Name: KIRSCHNER WIRE Ø2.0X285MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4222385
• MDR Text Key: 5078368
• Report Number: 0008031020-2014-00527
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971962
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 390191S
• Device Lot Number: F05836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2014
• 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): Required Intervention