MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 18965070S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Hospital policy.

Event Description

It was reported that patient's right tibia was revised after patient walked on the rod and displaced it.Rep reported that he has no access to any additional information due to not being allowed access to the hospital's password-protected systems.Rep reported that the nail and 5 screws (3 proximal, 2 distal) were explanted.Hospital implant sheet shows a nail and 6 screws.Additional info received from rep's email: there was a screw exchange from the primary surgery due to length.Only 5 screws were implanted.In initial surgery, a 6th screw was used but immediately taken out.He does not know which screws were used and which one was not used.The distal tibia displaced not the tibial rod.Additional info received from phone call with rep: revision needed because "patient walked on leg when shouldn't have" and the bone moved.Surgeon felt that plates gave a better reduction so he switched from the nailing system to plating.

Event Description

It was reported that patient's right tibia was revised after patient walked on the rod and displaced it.Rep reported that he has no access to any additional information due to not being allowed access to the hospital's password-protected systems.Rep reported that the nail and 5 screws (3 proximal, 2 distal) were explanted.Hospital implant sheet shows a nail and 6 screws.Additional info received from rep's email: there was a screw exchange from the primary surgery due to length.Only 5 screws were implanted.In initial surgery, a 6th screw was used but immediately taken out.He does not know which screws were used and which one was not used.The distal tibia displaced not the tibial rod.Additional info received from phone call with rep: revision needed because "patient walked on leg when shouldn't have" and the bone moved.Surgeon felt that plates gave a better reduction so he switched from the nailing system to plating.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7551204
• MDR Text Key: 109488591
• Report Number: 0009610622-2018-00223
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 04546540202550
• UDI-Public: 04546540202550
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965070S
• Device Lot Number: K0447FA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR