MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STIRRUP WIRE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Discomfort (2330); Post Operative Wound Infection (2446)

Event Date 05/04/2020

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 unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from geisinger community medical center, united states.The title of this report is ¿a presentation of the last 20 consecutive cases using the hoffman lrf hexapod for limb salvage and deformity correction.¿ which is associated with the stryker ¿hoffmann lrf¿ system.The treatment period of patients included in this report was between 2018 and 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 9 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses wire discomfort and superficial pin infection treated with local care and antibiotics.The report states: ¿the varus correction program lasted 21 days which took 28 days due to wire discomfort.The equinus correction program took 12 days as scheduled.Prior to correcting equinus, the stirrup wire was repositioned and attached to the footplate.Correction of this deformity was painful regardless of changes in the correction rhythm.Two of the pins were superficially infected on two occasions but successfully treated with local care and antibiotics.¿.

• Brand Name: UNKNOWN STIRRUP WIRE
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10186398
• MDR Text Key: 196218931
• Report Number: 0008031020-2020-01752
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• 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: 05/26/2020
• 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: 38 YR