MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW GAMMA3® 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200090
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, during a primary procedure on a left femur, when impacting the gamma nail, the holding bolt broke off in the patient's femur.The piece was removed from the patient and surgery was completed successfully with a delay of approximately 25-30 minutes.
Event or Problem Description
It was reported that, during a primary procedure on a left femur, when impacting the gamma nail, the holding bolt broke off in the patient's femur.The piece was removed from the patient and surgery was completed successfully with a delay of approximately 25-30 minutes.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail holding screw (nhs) shows evidence of heavy impacts around the rim.Edges of the impacted portions bulges outwards that indicates use of a sharp tool with impact, during implantation.Few areas show deformation which is plastic in nature.From one of the areas, some part is completely chipped off.A closer look in that area reveals breakage surfaces and all damage patterns reveal the fracture being a forced brittle fracture.Based on investigation, the root cause was attributed to a user related issue.The nhs was most likely impacted to implant a nail with hammer blows.Hammering the nhs directly is not allowed; the target device is marked with the marking ¿do not hit!¿ to prevent direct blows with a hammer.The broken nhs is related to an abnormal usage.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: NAIL HOLDING SCREW GAMMA3® 8X35MM
• 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: 8697598
• Report Number: 0009610622-2019-00487
• Device Sequence Number: 19293856
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 13200090
• Device Lot Number: KSS171888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1