MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ORTHOLOC¿ SPS; PLATE, FIXATION, BONE

Model Number	SPS007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to post-operative complication (non union), likely due to non-compliance.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to post-operative complication (non union), likely due to non-compliance.
Additional Manufacturer Narrative
The reported event was confirmed by x-rays provided for evaluation.A device inspection was not possible since the affected device was not returned.The medical opinion of a medical expert was requested to evaluate the risk of this event: "the patient sustained a b2 fracture (boileau type 3), which is known for its unpredictable outcome.There are various muscles acting on the bone fragments, not only creating predictable fracture patterns, but also creating forces that counteract fracture reduction." "in this case, the fracture didn¿t heal and then breakage of the implant is unavoidable over time.I didn¿t notice hardware pull-out on the available x-rays (still the surgeon may have noticed some during revision surgery).The secondary dislocation of the fracture fragments (in this case the humeral head in varus and the humerus at the level of the fracture) will dislocate further as result of these muscle forces and is not a result of hardware pull-out." "the plate fractured as an unavoidable sequence of a non-union of the metaphyseal component of the fracture." 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.

• Brand Name: ORTHOLOC¿ SPS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12470780
• Report Number: 3004983210-2021-00066
• Device Sequence Number: 4853258
• Product Code: HRS
• UDI-Device Identifier: 00846832074006
• UDI-Public: 00846832074006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: SPS007
• Device Catalogue Number: SPS007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 95 KG