MAUDE Adverse Event Report: STRYKER GMBH FOOT ARCH HOFFMANN LRF 180MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 4934-6-180

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Foot arch on hlrf has detatched from frame 8+ weeks post initial surgery.Patient has underwent surgery to revise frame.Patient has had to undergo subsequent surgery for this issue plus replacement of a few other components.

Manufacturer Narrative

The reported event that foot arch hoffmann lrf 180mm was alleged of 'instrument breakage identified out of surgery' could be confirmed, based on provided picture.Based on investigation, the root cause was attributed to be patient related.The failure was caused by overlaoding of the device.It was reported that patient is overweighted, has no sensation in the foot as diabetic and may not be weight bearing properly (putting weight on the more medial aspect of his foot).A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not return.

Event Description

Foot arch on hlrf has detatched from frame 8+ weeks post initial surgery.Patient has underwent surgery to revise frame.Patient has had to undergo subsequent surgery for this issue plus replacement of a few other components.

• Brand Name: FOOT ARCH HOFFMANN LRF 180MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7475053
• MDR Text Key: 106955074
• Report Number: 0008031020-2018-00334
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613252611509
• UDI-Public: (01)07613252611509
• Combination Product (y/n): N
• PMA/PMN Number: K130907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4934-6-180
• Device Catalogue Number: 49346180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention