MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø8X250 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18300825S

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report. Device is not available.

Event Description

The customer reported that they inserted a left humeral nail, there was then difficulty with distal locking the nail. Upon removing the targeting device, it was noticed that the humeral nail itself was damaged insitu. The surgery was completed upon removing the debris with a standard approach. An end cap was placed on the nail, and the wound was closed. Item remained insitu within the patient. Debris pieces unable to be attained as damaged upon removing from patient.

Manufacturer Narrative

Product inquiry stated the humeral nail t2 humerus ø8x250 mm to be the subject product. No further associated products were reported. Review of the device history records revealed no discrepancies. The item reported was documented as faultless prior to distribution. A physical examination of the item could not be carried out as the device was not received for evaluation (implanted). From previous cases we have known that a damage of the nail reception may occur when the nail is fixed onto the target device in a wrong position, i. E. That the pegs of the nail adapter had been placed on the rim of the nail instead of being inserted into the intended position in the reception of the nail. Furthermore the breakage of the nail reception might occur when the nail holding screw was not sufficiently tightened during rotating the target device in order to advance the nail to its desired position as a positive (frictional) connection between nail and nail adapter was not achieved. This is consistent with the received information. According to information received two seating slots of the nail reception snapped off most likely due to the nail holding screw becoming loose. When the targeting arm was moved during distal locking the seating slots broke off as a positive (frictional) connection between nail and nail adapter was no longer given. The broken seating slots could be removed from the patient. The attending surgeon did not believe that a nail exchange would be required. Based on the above information the root cause of the reported event was not linked to a deficiency of the device, but was rather user related. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject product(s). No non-conformity was identified.

Event Description

The customer reported that they inserted a left humeral nail, there was then difficulty with distal locking the nail. Upon removing the targeting device, it was noticed that the humeral nail itself was damaged insitu. The surgery was completed upon removing the debris with a standard approach. An end cap was placed on the nail, and the wound was closed. Item remained insitu within the patient. Debris pieces unable to be attained as damaged upon removing from patient.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø8X250 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: 5753835
• Report Number: 0009610622-2016-00322
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K032523
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/30/2020
• Device Catalogue Number: 18300825S
• Device Lot Number: K037A61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Other