MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX HAND LOCKING PLATE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Necrosis (1971); Pain (1994); Swelling (2091); Injury (2348); Post Operative Wound Infection (2446)

Event Date 05/13/2020

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 bg klinik tubingen, germany.The title of this report is ¿retrospective data collection report pmcf variax hand.¿ which is associated with the stryker ¿variax hand locking plate¿ system.The investigation for the patients included in this report was performed between 5 november 2018 and january 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 20 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses infection & lymphangitis with partial necrosis & pain followed by hardware removal.The report states: ¿a (b)(6) year old female had a purulent infection of the hand and lymphangitis, a plate infection with subsequent partial necrosis of the m.Interosseus dorsalis of the metacarpal bone v.She still retained restricted mobility of the small finger and a complex-regional-pain-syndrom.Radiographic and clinical consolidation was observed eventually.However, the subject was not pain free at consolidation.Hardware removal was performed 28 days after initial surgery due to a pronounced plate infection.After the removal, the hand remained swollen and painful for at least 6 months.This case is the only adverse event considered to be device related.¿.

• Brand Name: UNKNOWN VARIAX HAND 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: 10200885
• MDR Text Key: 198095071
• Report Number: 0008031020-2020-01783
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: DE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR