MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200100

Device Problem Failure to Align (2522)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The pharmacist reported that: "we inform you of a material vigilance sent today to ansm about a trochanteric gamma 3 nail. Indeed ,the surgeon had to abandon the distal locking of a gamma nail because of misalignment of the distal locking hole. " "event description: abandoning the distal locking of a gamma nail because of misalignment of the distal locking hole with the nail holder. Possibility of a nail holder calibration defect. Risk involved: collapse of the trochanter. ".

• Brand Name: TARGET DEVICE GAMMA3 300X160MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10140058
• MDR Text Key: 195168056
• Report Number: 0009610622-2020-00283
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 13200100
• Device Lot Number: KME904382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse