MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT SCREW

Catalog Number UNK_FRO

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

The sales rep reported on behalf of the customer that while placing a variax distal radius plate 3 screws broke.The heads of the screws broke off.The surgeon reported not to have used excessive force while placing the screws.The surgeon continued the procedure with the same plate.The ends of the screws are still present in the plate.The surgeon attached the plate by placing additional screws very carefully.The surgeon choose to use a 2.0 burr to attach the 3.0 screws.

Manufacturer Narrative

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

Manufacturer Narrative

The reported incident that unknown_fro_product was alleged of issue s-11 (breakage during surgery) could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by too much high torsional force during insertion.The device inspection revealed the following: as indicated on the event description; ¿the customer continued the procedure with the same plate.The surgeon attached the plate buy screwing in additional screws very carefully.As an action and in order to be careful not to break the final screws, the surgeon choose to use a 2.0 burr to attach the 3.0 screws.¿ this gives us a clear indication that the surgeon did not predrilled prior to screw insertion (also possible hard bone material could have cause some problem, unfortunately no information regarding bone strengths has been given).Please see ifu below for further details, in order to prevent such problems in the future.The instruction for use (90-03200 rev g 03-2014 implants dr, non locking ifu_low res vax_ifu-2); 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.Locking screws may not lock properly into the plates long elliptical hole.Therefore we recommend using regular bone screws.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 and leading to optimal friction fit performance.Screws should not be over tightened during insertion.Excessive over tightening will compromise the integrity of the screw head, result in possible screw and screwdriver blade breakage or deformation, and lead to loss of friction fit performance.Excessive tightening of the locking screw may lead to titanium particle generation.Particles should be removed to prevent potential inflammation.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.A review of the device history was not possible because the article number nor the lot number was communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.

Event Description

The sales rep reported on behalf of the customer that while placing a variax distal radius plate (b)(4) screws broke.The heads of the screws broke off.The surgeon reported not to have used excessive force while placing the screws.The surgeon continued the procedure with the same plate.The ends of the screws are still present in the plate.The surgeon attached the plate by placing additional screws very carefully.The surgeon choose to use a 2.0 burr to attach the 3.0 screws.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT SCREW
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4685123
• MDR Text Key: 5642432
• Report Number: 0008010177-2015-00070
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/19/2015

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: UNK_FRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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