MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 100MM LENGTH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 33625100

Device Problems Degraded (1153); Disconnection (1171); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 03/16/2014

Event Type  malfunction  

Event Description

It was reported that lag screw was inserted in the femoral head after traditional measuring techniques.Lag screw wrench and internal connection rod disconnected from the lag screw.Residents were asked to reinsert the teeth of the wrench under floro then rethread the internal connection rod.They felt that they had done so, but could not advance or remove lag screw and felt that the teeth and internal threads in the lag screw had stripped and we needed to explore other options to advance the screw to desired its desired position.

Manufacturer Narrative

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

Manufacturer Narrative

The reported incident that standard lag screw omega 100mm length was alleged of issue s-21 (device stripped / twisted) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection on the returned connecting bolt indicate the following; some damages on the tread turns are clearly evident.Tests with a new lag screw showed though, that the bolt could still be screwed in and out without any problem.The damages on the treaded part of the returned connecting screw may indicate that the inner thread of the used lag screw (implanted) may have been damaged during insertion.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.If any further information is provided, the investigation report will be updated.

Event Description

It was reported that lag screw was inserted in the femoral head after traditional measuring techniques.Lag screw wrench and internal connection rod disconnected from the lag screw.Residents were asked to reinsert the teeth of the wrench under floro then rethread the internal connection rod.They felt that they had done so, but could not advance or remove lag screw and felt that the teeth and internal threads in the lag screw had stripped and we needed to explore other options to advance the screw to desired its desired position.

• Brand Name: STANDARD LAG SCREW OMEGA 100MM LENGTH
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3738132
• MDR Text Key: 4223112
• Report Number: 0008031020-2014-00155
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2014

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: Health Professional
• Device Catalogue Number: 33625100
• Device Lot Number: R34159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2014
• Initial Date FDA Received: 04/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• 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
• Patient Age: 62 YR