MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HOFFMANN THIN WIRE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Deformity/ Disfigurement (2360); 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 2 broken halfpins with thin wire infection and below knee amputation.The report states: ¿the patient was referred to our clinic following 3 failed attempts at fusion by a skilled foot and ankle surgeon.The left ankle is unstable and there is a lateral malleolar noninfected ulcer.The patient is obese and confined to a wheelchair.It was unclear if there was any underlying bone infection so imaging was performed.Patient had a positive ceretec wbc scan and positive sulphur colloid scan read as over a 90% chance of no bone infection.Based on this a 4th attempt of fusion was agreed upon with the understanding that if this was unsuccessful, amputation would be the likely result.Past medical history was positive for type 2 diabetes with profound peripheral neuropathy, unstable bilateral charcot arthropathy, peripheral arterial disease, asthma and seizure disorder.Past surgical history included 3 failed tibio-talo-calcaneal (ttc) fusions of the left lower extremity.The patient¿s postoperative course was very difficult with 2 broken halfpins and numerous thin wire infections.Although the deformity was corrected, the inflammation and infection could not be controlled.Nine weeks postop the frame was removed and a below knee amputation was performed.¿.

• Brand Name: UNKNOWN HOFFMANN THIN 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10185612
• MDR Text Key: 196219227
• Report Number: 0008031020-2020-01740
• Device Sequence Number: 1
• Product Code: HTY
• 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?: 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: 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): Hospitalization; Disability
• Patient Age: 58 YR