MAUDE Adverse Event Report: STRYKER TRAUMA KIEL EXTRACTION ROD, CONICAL T2 TIBIA Ø8 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Extraction rod broke during explantation of a t2 tibia nail.Surgical delay of 5min.Not longer.No other consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged failure.Visual inspection of the received extraction rod, conical t2 tibia shows traces of frequent and intense use.Dents were found in proximal threaded region.Product was broken along the threads.The breakage surface shows a smooth structure.The appearance of the breakage surfaces revealed the product had broken in brittle manner.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The operative technique instructs user to ¿lightly hammer the conical extractor in order to fully engage the cutting flutes.¿ based on investigation, the root cause was attributed to a user related issue.The failure was most likely caused due to applying excessive force while hammering.As the device had been in use for more than 6 years (manufactured in 2012), we can safely say that the device had fulfilled its tasks in former surgeries as intended.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Extraction rod broke during explantation of a t2 tibia nail.Surgical delay of 5min.Not longer.No other consequences reported.

• Brand Name: EXTRACTION ROD, CONICAL T2 TIBIA Ø8 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8341309
• Report Number: 0009610622-2019-00069
• Device Sequence Number: 11333802
• Product Code: LXH
• UDI-Device Identifier: 04546540196439
• UDI-Public: 04546540196439
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 18060350
• Device Lot Number: K267737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other