MAUDE Adverse Event Report: SMITH+NEPHEW LYON UNKNOWN HALLU LOCK IMPLANT; PLATE, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a mtp1-arthrodesis performed in an unspecified date, the patient started to experience pain symptoms from the hallu-lock plate, the plate was giving burden.A revision surgery was performed on (b)(6) 2023 to remove the plate.It is unknown the current health status of the patient.

Event Description

It was reported that, after a mtp1-arthrodesis performed in an unspecified date, the patient started to experience pain symptoms from the hallu-lock plate, the plate was giving burden.A revision surgery was performed on (b)(6) 2023 to remove the plate.Also, two (2) screws were unable to be removed.The other screws were over-drilled and removed.It is unknown the current health status of the patient.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the product has not been received at the lyon site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed: complaint history review: the complaint history review identify no previous similar reported event for the associated product family (no part and lot numbers provided) and it is not possible to review the failure rate for the lot number as no lot number was provided.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (done for the product family): 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: no review of the dhr / batch record can be done as not lot number was provided in the reported information.Capa/nc/pra/hhe/field action review (done for the product family): 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 (done for the product family): identified no issues which could have caused or contributed to the reported event.This review determined that the devices from the concerned product family met labeling requirements upon release for distribution.Medical investigation: the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Per report, the surgeon was unable to remove two of the implantable screws.Nevertheless, the retained screws are biocompatible and since they were left in the bone, micro-motion and/or migration of the retained screws is unlikely.According to the report, the other screws were over drilled and removed.It was reported the procedure was completed with a 30-minute surgical delay; however, the current health status of the patient is unknown.The impact to the patient beyond that which has already reported cannot be confirmed nor concluded.It could not be determined whether the device contributed to the reported event.According to risk management documentation for the hallulock implants, surgical gesture or postoperative precaution is identified as failure mode which could result in pain requiring withdrawal.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.Corrected data: b1 (type of event), b5 (narrative), d9 (product not available for analysis), h6 (health effect - impact code).

• Brand Name: UNKNOWN HALLU LOCK IMPLANT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH+NEPHEW LYON; immeuble sequoia 2; saint priest rhone 69800 ; FR 69800
• Manufacturer (Section G): SMITH+NEPHEW LYON; immeuble sequoia 2; saint priest rhone 69800 ; FR 69800
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16935582
• MDR Text Key: 315266872
• Report Number: 3002952164-2023-00004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN ASSOCIATED SCREW (X2)
• Patient Outcome(s): Required Intervention