MAUDE Adverse Event Report: ORTHOFIX INC. FORZA PTC; STRAIGHT IMPLANT ASSEMBLY

Model Number	89-0114
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
2 pcs 9mm straight implant shaft assembly instruments from set were involved in incident.89-0114, lot# 39361-ol31, (b)(4), manufacture date: 12/31/2012.89-0114, lot# 37566-nf09-a, (b)(4),) manufacture date: 06/09/2011.
Event or Problem Description
Information provided states that during a l4-l5 transforaminal lumbar interbody fusion (tlif) case the metal prong tips broke off of the implant inserters.The surgeon removed the prongs from the disk space which resulted in a delay in the case.The patient was not affected by the breakage.The case was successful in the end.

• Brand Name: FORZA PTC
• Common Device Name: STRAIGHT IMPLANT ASSEMBLY
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 8001776
• Report Number: 2183449-2018-00030
• Device Sequence Number: 13503526
• Product Code: LXH
• UDI-Device Identifier: 18257200076994
• UDI-Public: 18257200076994
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2018

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: Health Professional
• Device Model Number: 89-0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR