MAUDE Adverse Event Report: TORNIER INC ORTHOLOC SPS 185MM STANDARD 10 HOLE PLATE; PLATE, FIXATION, BONE

Catalog Number	SPS010
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a revision procedure due to the sps plate breaking.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, based on the available pictures, x-rays and medical expert opinion.The device inspection revealed the following: the visual inspection of the available picture of the device confirms that the implant is broken.A review of the x-rays by the medical expert stated; ¿plate was used as intended and the surgeon used a proper technique.The plate was used as a revision of an earlier non-union of a mid-shaft humerus fracture.This can be seen by the screw tracts that can be seen in part of the humerus distally to the non-union.The reason behind the breakage of plate is unsuccessful revision of earlier non-union after orif followed by the insufficient healing of bone.¿ a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on investigation and formal medical expert opinion, the root cause was attributed to patient related issue.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient presented for a revision procedure due to the sps plate breaking.

• Brand Name: ORTHOLOC SPS 185MM STANDARD 10 HOLE PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19760670
• Report Number: 0001649390-2024-00319
• Device Sequence Number: 8513529
• Product Code: HRS
• UDI-Device Identifier: 00846832074013
• UDI-Public: 00846832074013
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K181587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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 Catalogue Number: SPS010
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 4 MO
• Patient Sex: Male