MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SPEEDLOCK SLEEVE GAMMA3® 200; INSTRUMENT

Catalog Number 13201120

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

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

Event Date 03/22/2015

Event Type  malfunction  

Event Description

It is reported by male nurse of the hospital that there was a missdrilling of the femoral neck screw for the gamma 3 nail.During locking the of the drill sleeve with the speedlock sleeve the drill sleeve twisted and the drill got in contact with the nail.Procedure was completed successfully by multiple x-rays and a slight manipulation of the target device.

Manufacturer Narrative

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

Manufacturer Narrative

Deviations in the inspection documents were not found.The item returned was documented as faultless prior to distribution and as it had been in use for a longer time (approximately 3 1/2 years) we pre-suppose that this speedlock sleeve had fulfilled its tasks in former surgeries as intended.The returned speedlock sleeve passed the pre-operative function test as intended.The speedlock sleeve could be assembled onto the target device.Also a sample nail and all other required instruments could be assembled.The alleged proximal targeting issue could not be confirmed.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intraoperative assembly of speedlock sleeve onto target device or not turning the speedlock sleeve knob into the "lock" position which is described in the operational technique.

Event Description

It is reported by male nurse of the hospital that there was a mis-drilling of the femoral neck screw for the gamma 3 nail.During locking the of the drill sleeve with the speedlock sleeve the drill sleeve twisted and the drill got in contact with the nail.Procedure was completed successfully by multiple x-rays and a slight manipulation of the target device.

• Brand Name: SPEEDLOCK SLEEVE GAMMA3® 200
• Type of Device: INSTRUMENT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4682033
• MDR Text Key: 5636344
• Report Number: 0009610622-2015-00165
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 13201120
• Device Lot Number: KP314144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2011
• 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