MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX M PLATE 3; IMPLANT

Catalog Number UNK_SEL

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 11/18/2020

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.

Event Description

The manufacturer became aware of a pmcf published by klinikum aschaffenburg ¿ alzenau, in germany.The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of hand and wrist fractures with the stryker hand plating system¿ which is associated with the stryker ¿ variax hand locking and profyle standard¿ system.This report includes research done on 105 patients between the period may, 2019 and april, 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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses material failure with breakage of all 3 plates and significant callus formation followed by revision surgery.The report states: ¿p.18.38 was a (b)(6) man who suffered fractures to metacarpals ii, iii, and iv due to a severe blow to his right hand (ao: 77.2.2 b, 77.3.2 a, 77.4.2 a).Metacarpal ii was a i° open fracture.The treatment was carried out using one variax m stryker plate each (i.E.A total of 3) and wound debridement.The follow-up treatment was released as usual by means of free, passive physiotherapy without load for a total of 6 weeks.Because of the open fracture situation, antibiotic therapy with cefuroxime 500 mg was administered twice daily for a total of 10 days.In the course of the treatment, the patient presented with persistent complaints and swelling.An x-ray examination showed a material failure with breakage of all 3 plates and significant callus formation.A revision and renewed osteosynthesis with unknown plates were performed.100 days later, with the help of an exogenous ultrasound therapy, the patient regained complete finger extension and fist closure.¿.

• Brand Name: UNKNOWN VARIAX M PLATE 3
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11035865
• MDR Text Key: 222294282
• Report Number: 0008031020-2020-02572
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/23/2020
• 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: 61 YR