MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN BROKEN PIN; IMPLANT

Catalog Number UNK_KIE

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient (b)(6) male; with mandibular fractures and comminuted and complex fracture of the proximal femur, intertrochanteric and subtrochanteric due to the explosion of a projectile from a fire arm; the surgeon performs the closed reduction in the trace ion table; the procedure begins and rhymes both proximally and distally; we passed a cephalomedullary nail of 11x 400 x 130º left surgeon makes the neck rolling with the pin with thread.The first pin is broken when wanting to do the work with the pin, but it is possible to remove it.The start a new reduction with a second threaded pin; if it is more, the sliding bit is passed; step the screw of 10.5 x 100mm, surgeon begins to introduce it, but only to see pass the first steps of the screw by the nail makes too much resistance, surgeon asked for a threaded bearing, taking into account that it is a very young patient, passes the marble of 10.5 which is the diameter of the cefallco screw test both the assistant and the surgeon but can't no introduce the screw.Surgeon decides to take out the nail, to see what is happening; obviously, the guide with olive is renewed.Tests are carried out and effectively the screw passes very strongly through the nail, but we are not quite sure if the defect is the screw or the nail.He decides to pass the screw cefallco first (we passed the 10.5x105mm), but it pass with difficult.The surgeon used the of 11x380x130º left and passed.The tests are made, a video is taken where it is evident that the nail is definitely the defect, (with the new nail, the torrent passes very smoothly and without problems).The reduction of the neck is repeated again, the screw is passed without inconvenience.The locking guide is used for long nails and is blocked the dynamic hole is locked without any problem.

Manufacturer Narrative

The reported event that unknown_kiel device was alleged of issue (instruments - broken, deformed, worn or scratched) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Patient (b)(6).Male; with mandibular fractures and comminuted and complex fracture of the proximal femur, intertrocanthic and subtrochanteric due to the explosion of a projectile from a fire arm; the surgeon performs the closed reduction in the trace ion table; the procedure begins and rhymes both proximally and distally; we passed a cephalomedullary nail of 11x 400 x 130º left surgeon makes the neck rolling with the pin with thread.The first pin is broken when wanting to do the work with the pin, but it is possible to remove it.The start a new reduction with a second threaded pin; if it is more, the sliding bit is passed; step the screw of 10.5 x 100mm, surgeon begins to introduce it, but only to see pass the first steps of the screw by the nail makes too much resistance, surgeon asked for a threaded bearing, taking into account that it is a very young patient, passes the marble of 10.5 which is the diameter of the cefallco screw test both the assistant and the surgeon but can't no introduce the screw.Surgeon decides to take out the nail, to see what is happening; obviously, the guide with olive is renewed.Tests are carried out and effectively the screw passes very strongly through the nail, but we are not quite sure if the defect is the screw or the nail.He decides to pass the screw cefallco first (we passed the 10.5x105mm), but it pass with difficult.The surgeon used the of 11x380x130º left and passed.The tests are made, a video is taken where it is evident that the nail is definitely the defect, (with the new nail, the torrent passes very smoothly and without problems).The reduction of the neck is repeated again, the screw is passed without inconvenience.The locking guide is used for long nails and is blocked the dynamic hole is locked without any problem.

• Brand Name: UNKNOWN BROKEN PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7102049
• MDR Text Key: 94962353
• Report Number: 0009610622-2017-00369
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other