MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X85 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965085S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/12/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was discarded.

Event Description

After the surgery, the physician felt there was not good enough bending action for patient's knee under xray and complete the procedure. Then it was confirmed by ct there was went through the patella by outer screw and it was reason for not good bending of the patients' knee. So removed the screw. In this time, there was improved bending action.

Manufacturer Narrative

Evaluation revealed the supracondylar nail t2 scn and the locking screws to be the primary products. No further associated products were reported. A physical examination could not be carried out as the devices were not received for evaluation. According to information received the supracondylar nail was still implanted whereas the locking screw had been discarded by the customer. A review of the device history records revealed no deviation in the manufacturing process. The devices were documented as faultless prior to distribution. Thus, we excluded deviations in material and manufacturing. In the case presented a patient had been treated with a supracondylar nail t2 scn. During the surgery the attending surgeon diagnosed an insufficient degree of freedom in the patient¿s knee via x-rays while bending. Ct radiographs were taken after the surgery showing the distal locking screw to have gone through the patella causing the limited motion. The distal locking screw was removed, which resolved the limited bending freedom. The received x-ray was forwarded to a consultant hcp for review, who confirmed that the distal locking screw had been inserted into the patellar surface by mistake. Based on the above the event was not linked to a deficiency of the devices, but was rather user related (incorrect implantation/ positioning of the distal locking screw). With available information a deficiency of the devices could not be verified. The file will be closed formally. In case relevant clinical information or the items should become available, we reserve the right to update the investigation and change the root cause. 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 products.

Event Description

After the surgery, the physician felt there was not good enough bending action for patient's knee under xray and complete the procedure. Then it was confirmed by ct there was went through the patella by outer screw and it was reason for not good bending of the patients' knee. So removed the screw. In this time, there was improved bending action.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X85 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: 6149805
• Report Number: 0009610622-2016-00609
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 18965085S
• Device Lot Number: K0D88FF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention