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

Catalog Number	71365705
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(6).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 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 implant impaction in a thr surgery, the tip of one (1) anthology inserter poster hard fractured and remained threaded into one (1) redapt slvls mono stem 300mm sz 21 ho.As the broken tip is threaded, it was unable to be removed.It is still inserted into the top of the implanted stem and surgery for removal is reportedly not required.No other pieces fell into the wound.The procedure was resumed, after a non-significant delay, using the same device.No injury was reported as a consequence of this issue and the patient has not experienced any symptoms after the procedure.
Additional Manufacturer Narrative
H3, h6: although the involvement of the stem was reported, the relationship with the investigated failure was directly associated to the anthology inserter.This device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported events could not be determined.Although, 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 were adhered to.The anthology inserter is made of stainless steel.This is an externally communicating device, it is neither manufactured nor intended for implantation.Additionally, it was not approved for long term internal tissue exposure and long-term implantation data is not available.Micro-motion or movement is unlikely since the tip was fractured and remained threaded into the stem.There is potential risk for tissue inflammation and/or pain.This may complicate a stem revision if required in the future.The patient impact is determined to be the retained broken anthology inserter tip and the prolonged surgery.The batch number for this device 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 this event was previously identified for the anthology inserter.It has been concluded that the occurrence of the described breakages are occurring at an acceptable level; therefore no more actions were initiated.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 POSTER HARD
• 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: 19745601
• Report Number: 1020279-2024-01382
• Device Sequence Number: 17775317
• Product Code: LZO
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113789
• Number of Events Summarized: 1
• Summary Report (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): 08/14/2024

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: 71365705
• Device Lot Number: UNKNOWN
• 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: 06/22/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male