MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L20MM; PLATE, FIXATION, BONE

Catalog Number	614620
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that locking screw variax full thread 3.5mm / l18mm was alleged of issue s-91 (tissue damaged) could not be confirmed, since the returned device is conforming to specifications.No other evidences were provided which could confirm the reported failure.Visual inspection of the returned locking screw was performed, and several scratches and dent marks were observed on the head of the screw which could have been resulted from high axial and torsional forces during extraction of the implants.Apart from that no major damage was observed on the surface of the screw.The reported failure of the tissue turning black could be a case of ¿metallosis¿.This is usually caused by friction of two metal parts resulting in an abrasion of finest nano-particles of titanium which are deposited in the surrounding soft tissue which is a frequent event.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.However, based on our risk management file, the most likely root cause is attributable to a user(ur) related issue.Some of the possible causes are: too long screw selected, screw head prominence, poor plate placement/contouring etc.A review of the labeling did not indicate any abnormalities.As already stated in op tech, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.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 or Problem Description
During extraction surgery, the surgeon found that the tissue has turned black.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6972970
• Report Number: 0008031020-2017-00632
• Device Sequence Number: 498351
• Product Code: HRS
• UDI-Device Identifier: 07613154969784
• UDI-Public: 07613154969784
• Combination Product (Y/N): N
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 614620
• Device Lot Number: V02969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention