MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS FOR RADIUS PLATE, CROSS-PIN, DIAM.2.7X18MM; IMPLANT

Catalog Number 52-27318

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 08/05/2014

Event Type  malfunction  

Event Description

During variax dr surgery, the locking screw did not lock to screw hole of plate.Another locking screw was able to lock to the same hole.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event that the locking screws for radius plate, cross-pin, diam.2.7x18mm was alleged not locking could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on the currently available information, the root cause could not be determined.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.Note, as stated in the ifu: screw precautions and warnings placement of all locking screws requires the use of a drill guide to ensure proper screw placement.If a drill guide is not used, the screw may not lock into the plate.When engaging the screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head.This results in proper axial alignment and full contact between driver and screw, minimizing the risk of damage.Screws should not be over-tightened during insertion.Excessive over-tightening will compromise the integrity of the screw head, result in possible screw breakage, and lead to loss of friction fit performance.Excessive tightening of the locking screw may lead to stripping of the locking threads.In the event that a locking screw thread strips out, a bone screw should be used.Each bone and/or locking screw should be additionally tightened upon completion of implantation to verify a rigid connection between the screw and plate.'' [original statement(s)] a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Note that this pi has been raised more than 4 months ago and not all information has been collected from the field.Due to the current workload and backlog situation in selzach pms, we won¿t try to gather further information regarding this event.This situation is being addressed by the capa.If any further information is provided, the investigation report will be updated.

Event Description

During variax dr surgery, the locking screw did not lock to screw hole of plate.Another locking screw was able to lock to the same hole.

• Brand Name: LOCKING SCREWS FOR RADIUS PLATE, CROSS-PIN, DIAM.2.7X18MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4053230
• MDR Text Key: 4901847
• Report Number: 0008010177-2014-00232
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 52-27318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other