MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PIP SZ. 10 PROXIMAL; HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO

Catalog Number	PIP-200-10P-WW
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a pip replacement surgery, while impacting the proximal component of the pip sz.10 proximal into the broached canal, the implant snapped in two, separating the stem from the head.The stem was lodged in the canal, which had to be burred out before replacing with another proximal component.No pieces fell into the patient.The procedure was resumed, after a non-significant delay, with a s+n back-up device in the original hole.Surgeon was happy with the second implant and the result was unaffected.The status of the patient is fine.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the device was not returned for evaluation.However, the photographs were reviewed and revealed that the pip sz.10 proximal is fractured.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with the implant and instrumentation manufacturing specification, all implants and instrumentation will be 100% visually inspected for any damaged areas.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Additional information: d5, d7a, d8, h8.

• Brand Name: PIP SZ. 10 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: 21066321
• Report Number: 3002788818-2025-00001
• Device Sequence Number: 3279182
• Product Code: OMX
• UDI-Device Identifier: 00885556858400
• UDI-Public: 885556858400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: H010005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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 Catalogue Number: PIP-200-10P-WW
• Device Lot Number: 210858E
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/29/2025
• 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
• Patient Sex: Unknown