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

Model Number	4934-6-180
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7475053
• Report Number: 0008031020-2018-00334
• Device Sequence Number: 16573670
• Product Code: KTT
• UDI-Device Identifier: 07613252611509
• UDI-Public: (01)07613252611509
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K130907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 4934-6-180
• Device Catalogue Number: 49346180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention