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	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Foot arch on hlrf distal tibial frame has detached carbon ring from metal attachment post.Patient at present has foot arch still attached as surgeon has forced it back together.It is anticipated that patient will have to have this revised.
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.Since the affected device was not returned and the lot number was not communicated, it is not possible to know according which revision the product has been manufactured.However, based on provided picture, we can confirm the affected device is not from revision c but from anterior revision (a or b); connection pins have a new design on revision c.Design change was performed for revision c of the drawing # 4934_6_100 (design change # sel 16-244) in order to increase the strength connection between metal and carbon parts of foot arch hoffmann lrf 180mm.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.
Event or Problem Description
Foot arch on hlrf distal tibial frame has detached carbon ring from metal attachment post.Patient at present has foot arch still attached as surgeon has forced it back together.It is anticipated that patient will have to have this revised.

• 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: 7475069
• Report Number: 0008031020-2018-00335
• Device Sequence Number: 334065
• 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): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/27/2018
• 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: Other