MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35300380S

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/21/2014

Event Type  Injury  

Event Description

Patient had primary gamma nail, patient fell and fractured both the nail and bone.Nail broke at lag screw insertion.Surgeon replaced gamma nail with t2 nail.Surgeon suspected myeloma.

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Manufacturer Narrative

The nail was classified as primary product during investigation.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.Because the nail and further information like x-rays and surgery reports were not available an investigation of the nail was not possible; the root cause is unknown.The customer reported that the patient fell and the treated bone and implanted nail broke.Furthermore myeloma is reported.It is very likely that the nail broke due to the fall; due to high bending forces the nail was overloaded.If the myeloma did also contribute to the nail breakage cannot be excluded.Additional trauma and bone diseases are listed as adverse effects in the ifu.Because no manufacturer related issues were found the case is attributed to a patient issue.No non-conformity identified.Device not available.

Event Description

Patient had primary gamma nail, patient fell and fractured both the nail and bone.Nail broke at lag screw insertion.Surgeon replaced gamma nail with t2 nail.Surgeon suspected myeloma.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 130°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4247419
• MDR Text Key: 5049096
• Report Number: 0009610622-2014-00633
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 35300380S
• Device Lot Number: K114823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 11/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR