MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965050S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The surgeon reported that the patient had undergone a t2 recon nail procedure on 2nd december 2017 and after the procedure it was noticed that the t2 5mm locking screw had backed out.

Event Description

The surgeon reported that the patient had undergone a t2 recon nail procedure on (b)(6) 2017 and after the procedure it was noticed that the t2 5mm locking screw had backed out.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.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 Ø5X50 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
• MDR Report Key: 7773460
• MDR Text Key: 116787791
• Report Number: 0009610622-2018-00684
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: 04546540202512
• 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
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965050S
• Device Lot Number: KD42BA5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR