MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE LAG SCREW CONNECTOR GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200330

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Attempted to turn left the u lag screw connector by the t handle after inserted the u blade.The u lag screw connector was broken, it was turned manually and removed the u lag screw connector.

Manufacturer Narrative

Event description indicates the u-blade lag screw connector to be the primary product.No further associated products are reported.Deviations in the device history records / inspection records were not found.Mechanical properties of material and dimensions in the relevant undamaged areas are within specified tolerances.The u-blade lag screw connector returned was documented as faultless prior to distribution, and as it had been in use for at least seven years, we pre-suppose that it had fulfilled its tasks in former surgeries as intended without problems reported.Appearance of the breakage surfaces in combination with slightly oblique fracture line indicates that the device broke in a forced brittle manner due to disproportional force and/or bending stresses by levering the instrument.Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to improper handling.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

Attempted to turn left the u lag screw connector by the t handle after inserted the u blade.The u lag screw connector was broken, it was turned manually and removed the u lag screw connector.

• Brand Name: U-BLADE LAG SCREW CONNECTOR GAMMA3®
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6094437
• MDR Text Key: 60080677
• Report Number: 0009610622-2016-00505
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200330
• Device Lot Number: K170280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other