MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CATALYSTEM BROACH SZ 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71314201
Medical Device Problem Codes	Flaked (1246); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr, the calcar planer small became stuck midway while reaming toward the catalystem broach sz 1 and could not be removed.The surgeon reversed the rotation, after which the instrument could be extracted.Metal wear particles were observed on the calcar planer small, and these particles fell into the patient¿s anatomy; however, it is unknown whether they were removed.Damage was also noted on the connection area of the catalystem broach sz 1.Due to this damage, the broach had to be removed from the femur using pliers, after which it was replaced with a catalystem broach sz 2.With the size 2 broach, the height extended above the osteotomy surface, so the calcar planer small was not used further.The procedure was completed after a 15-minute surgical delay using a similar s+n backup device.No additional complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use 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 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.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The visual inspection revealed that the devices are worn from use.For the broach the proximal end of the broach is abraded and degraded.Rendering the device inoperable.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk levels are still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.These devices are a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: CATALYSTEM BROACH SZ 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23708841
• Report Number: 1020279-2025-02004
• Device Sequence Number: 10726797
• Product Code: LZO
• UDI-Device Identifier: 00885556892114
• UDI-Public: 885556892114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 71314201
• Device Lot Number: 24HSY0031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 05/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NO.: 71313137, LOT NO.: 4766404412.; PART NO.: 71314202, LOT NO.: UNKNOWN.
• Patient Sex: Female