MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREWDRIVER GAMMA3® 380X110MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13200200

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 03/12/2014

Event Type  malfunction  

Event Description

It was reported that sales rep dropped off and said "the hospital asked for a new one because this one was damaged." no other details were provided.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the returned device matched the report and the reported event was confirmed.Review of the manufacturing and inspection records revealed no discrepancies.The item returned was documented as faultless prior to distribution.As the lag screwdriver had been in use for a longer time (manufactured in 2008) we pre-suppose that the device had fulfilled its tasks in former surgeries as intended.The broken off pegs of the lag screwdriver are a result of an inadequate usage.The appearance of damage indicates that the screwdriver had been operated under high force in ccw / untightening direction, whilst the pegs were not entirely engaged in the slots of the lag screw.In case of intended use such damage would not have occurred.A pre-damaging of the instrument in prior surgeries could not be excluded.Based on the above facts the root cause of the reported event is not related to a deficiency of the device, but is rather linked to rough handling by the user.No non-conformity was identified.

Event Description

It was reported that sales rep dropped off and said "the hospital asked for a new one because this one was damaged." no other details were provided.

• Brand Name: LAG SCREWDRIVER GAMMA3® 380X110MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL 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: rose mincieli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3732705
• MDR Text Key: 4321663
• Report Number: 0009610622-2014-00157
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

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: Other
• Device Catalogue Number: 13200200
• Device Lot Number: K743956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 04/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2008
• 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