MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PIP SZ. 20 PROXIMAL; HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO

Model Number	PIP-200-20P-WW
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a pip total joint surgery, the pip sz.20 proximal sheared off when impacted gently into the patient¿s middle phalangeal bone of patient left ring finger.The implant stem was embedded in the patient medullary canal and it was removed using a k wire drilled into the middle phalanx, proximal to the implant, before implanting a replacement.Surgery was resumed, after a non-significant delay, with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: as the product has not been received at the aus site for evaluation and photographs were not provided, the reported event could not be confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified similar reported events for this device but not for the same product lot.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: could not determine probable cause or contributing factors as smith and nephew has not received the requested patient specific documentation, the explanted device, and/or adequate materials to fully evaluate the root cause of the complaint.As the device has not been received for evaluation, a definitive root cause could not be determined.The complaint alleges that medical intervention beyond the standard of care was required to address the reported event.As the device has not been received for evaluation, it could not be determined whether the device contributed to the reported event.No discrepancies against the device¿s manufacturing specifications were identified.The pip proximal implant is an implantable device made of pyrocarbon, a material which is known to exhibit brittle overload fracture when subjected to excessive or bending forces.Intra-operative fracture is a known failure mode for the pip implant as documented in the risk-benefit analysis for the pip product line.Potential root causes include inadequate or incorrect surgical technique, such as incorrect bone preparation, and incorrect handling of the implant.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.Internal complaint reference number: (b)(4).

• Brand Name: PIP SZ. 20 PROXIMAL
• Common Device Name: HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15048307
• Report Number: 3002788818-2022-00049
• Device Sequence Number: 5515198
• Product Code: OMX
• UDI-Device Identifier: 10381780000471
• UDI-Public: 10381780000471
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: H010005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: PIP-200-20P-WW
• Device Catalogue Number: PIP-200-20P-WW
• Device Lot Number: 195590T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2019
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female