MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER ANT SOFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71365721
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during a thr surgery, the nipple tip of the anthology inserter ant soft device got fractured and was left inside the patient without notice.The surgeon was not aware of it, until after 6 weeks, during a post-op appointment.The piece dislodged from where it originally broke off (treads on the proximal part of the implant).Surgery to remove the broken instrument has not been confirmed yet.Current health status of patient is unknown.
Additional Manufacturer Narrative
B5: describe event or problem, h6: health effect - impact code.
Event or Problem Description
It was reported that during a thr surgery, the nipple tip of the anthology inserter ant soft device got fractured and was left inside the patient without notice.The surgeon was not aware of it, until after 6 weeks, during a post-op appointment.The piece dislodged from where it originally broke off (treads on the proximal part of the implant).No symptoms were reported.Surgery to remove the broken instrument has not been confirmed yet.Current health status of patient is unknown.
Event or Problem Description
It was reported that during a thr surgery, the nipple tip of the anthology inserter ant soft device got fractured and was left inside the patient without notice.The surgeon was not aware of it, until after 6 weeks, during a post-op appointment.The piece dislodged from where it originally broke off (treads on the proximal part of the implant) and was floating in the patient´s hip.No symptoms were reported.Surgery to remove the broken instrument was performed on (b)(6) 2024.No further information reported.
Additional Manufacturer Narrative
B5: describe event or problem h6: health effect - impact code.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, several x-ray images were provided for review and confirm the reported event, however they do not indicate the root cause for the breakage.Based on the information provided the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the surgical technique was adhered to, however it does caution that, ¿breaking of instruments can occur.Instruments which have experienced extensive use or excessive force are susceptible to fracture¿ and ¿instrument should be examined for wear, or damage, prior to surgery.¿ the patient impact is determined to be the subsequent procedure to remove the broken fragment.No further patient impact is anticipated.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is 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 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.

• Brand Name: ANTHOLOGY INSERTER ANT SOFT
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18974151
• Report Number: 1020279-2024-00606
• Device Sequence Number: 6154977
• Product Code: LZO
• UDI-Device Identifier: 03596010553409
• UDI-Public: 03596010553409
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71365721
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/01/2024; 04/04/2024; 04/25/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/02/2024; 04/18/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male