MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX DISTAL RADIUS LOCKING PLATE IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994); Non-union Bone Fracture (2369)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. 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 history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6) usa. The title of this report is ¿a retrospective data collection of the treatment of wrist fractures with the variax distal radius locking plate system¿ which is associated with the stryker ¿variax distal radius locking plate system¿ system. The research period of patients included in this report was between 9/2019 and 2/2020. It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints. Therefore, 20 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses prolonged stiffness, pain and delayed radiographic consolidation. The report states: ¿one subject was treated for an extra-articular fracture from a fall from standing. The subject had prolonged stiffness and pain and never reached clinical consolidation. The subject¿s husband was noted to be a heavy smoker, which may have contributed to the delayed radiographic consolidation. ¿.

• Brand Name: UNKNOWN VARIAX DISTAL RADIUS LOCKING PLATE
• Type of Device: IMPLANT
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10150997
• MDR Text Key: 195085063
• Report Number: 0008031020-2020-01641
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2020
• 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 Treatment Data

Date Received: 06/12/2020 Patient Sequence Number: 1