MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø7X220 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18300722S
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that on (b)(6) 2018, half past eleven a.M., the patient¿s right humerus was fractured.When the doctor put humeral nail t2 humerus into the patient.The near line of humeral nail t2 was broken.The fractured humeral nail was took out by the surgeon took out the fractured humeral nail and changed a replacement.During the replacement was connecting, the end line of replacement has slight deformation and color changed.It looks tend to be fracture.This surgery need blood transfusion.The complaint issue happened, which led to patient need more blood transfusion.
Additional Manufacturer Narrative
Corrections to (cat number, lot code, gtin).The reported event that humeral nail t2 humerus ø7x220 mm was alleged of issue (implant breakage ¿ nail) could be confirmed, since the device was returned for evaluation and matches with the alleged event.Visual inspection of the received humeral nail t2 humerus shows traces of use.Proximal end of the nail was deformed and broken, also threads were damaged.Visual inspection evaluates that nail was broken due to excessive torsional force applied on the nail.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to excessive torsional force on the nail by surgeon.Excessive torsional force could cause nail breakage in a situation where, intermedullary canal was reamed smaller than the diameter of the nail, and surgeon was trying to insert the nail by rotating target device or adjusting for alignment during drilling operation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that on (b)(6) 2018, half past eleven a.M., the patient¿s right humerus was fractured.When the doctor put humeral nail t2 humerus into the patient.The near line of humeral nail t2 was broken.The fractured humeral nail was took out by the surgeon took out the fractured humeral nail and changed a replacement.During the replacement was connecting, the end line of replacement has slight deformation and color changed.It looks tend to be fracture.This surgery need blood transfusion.The complaint issue happened which led to patient need more blood transfusion.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X220 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8269511
• Report Number: 0009610622-2019-00054
• Device Sequence Number: 16548409
• Product Code: HSB
• UDI-Device Identifier: 04546540201263
• UDI-Public: 04546540201263
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 18300722S
• Device Lot Number: K0A3DCF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/05/2019
• 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
• Patient Age: 51 YR