MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR HI PERF CUP INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 900001

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Event Description

It was reported that a bhr hi perf cup introducer was missing the two allen screws on the handle.It is unknown whether this happened during surgery or not; therefore, patient involvement can´t be confirmed.

Manufacturer Narrative

It was reported that a bhr hi perf cup introducer was missing the two allen screws on the handle.It is unknown whether this happened during surgery or not; therefore, patient involvement can´t be confirmed.As of today, the instrument, which was used in treatment and additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup introducer.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.It should be noted that the bhr surgical technique 04727 v2 45670103 revc 01/18 states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage".Without return of the actual instrument or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.Possible causes for this issue may be wear due to the age of the instrument or incorrect reprocessing of the instrument.If the product or additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H3, h6: it was reported that a bhr hi perf cup introducer (part number: 900001, lot: 1mp24104) was missing the two allen screws on the handle.It is unknown whether this happened during surgery or not; therefore, patient involvement can´t be confirmed.The instrument is for use in treatment.A review of the complaint history for the bhr cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup introducer.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.A visual inspection was performed on the device.During the visual inspection, marks and scratches were noted to be across the length of the device.All 3 arms on the device were completely detached.Heavy impact damage was noted on the head of the device.Cap screws are missing, the head revolves freely and does not tighten.Laser markings on the device are clear and legible.No functional evaluation has been performed as the possible failure was confirmed through visual inspection.This confirms the reported complaint.It should be noted that the bhr surgical technique states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage¿.Based on the available information, returned instrument findings and age of the instrument, the root cause is an end of life problem.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.The instrument will be retained at aurora.

• Brand Name: BHR HI PERF CUP INTRODUCER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11825525
• MDR Text Key: 250632252
• Report Number: 3005975929-2021-00251
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010503237
• UDI-Public: 03596010503237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900001
• Device Catalogue Number: 900001
• Device Lot Number: 1MP24104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1