MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L16MM; PLATE, FIXATION, BONE

Catalog Number 614616S

Device Problem Material Fragmentation (1261)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Variax clavicle primary surgery was performed on (b)(6) 2016.Then the bone was healing and the extraction surgery was performed on (b)(6) 2016.During the extraction surgery, a metal piece from the screw was found.

Manufacturer Narrative

The reported event that a locking screw variax full thread 3.5mm / l16mm was damaged during implant removal could be confirmed, as it was received and its thread resulted stripped.Based on investigation, the root cause was attributed to a user related issue.The most likely explanation is that the surgeon did not align the screwdriver with the screw axis and/or did not seat the screwdriver fully into the screw head.This caused slippage of the screwdriver during screw removal, leading to collision between screw thread and palte hole, thus resulting in screw stripping.The device inspection revealed the following: the screw thread is stripped for the whole of its length.The locking thread is impaired too.The screw head does not present any unusual pattern.One of the plate holes shows evident damage, thus most plausibly representing the hole where the screw thread had collision and stripped as a result.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.The operative technique (ies-st-1 rev 3 implant extraction set) was reviewed: ''screw stripping is commonly caused by slippage of a screwdriver that is not correctly aligned with the screw axis and/or fully seated.This may occur either during insertion or, more commonly, during attempted screw removal.'' [original statement(s)] the instruction for use (v15013 rev m non active implant ifu ot-ifu-105 rev 2) was reviewed: ''ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.[.] for your information, avail yourself of the training courses and publications offered.[.] intra-operative ¿ avoid surface damage of implants.[.] ¿ during the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.'' [original statement(s)] no indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

Variax clavicle primary surgery was performed on (b)(6) 2016.Then the bone was healing and the extraction surgery was performed on (b)(6) 2016.During the extraction surgery, a metal piece from the screw was found.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L16MM
• Type of Device: PLATE, FIXATION, BONE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5922251
• MDR Text Key: 54418276
• Report Number: 0008031020-2016-00426
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K101056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 614616S
• Device Lot Number: V03776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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
• Patient Age: 14 YR