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

Model Number	90128257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr surgery, the bhr curved cup introducer broke internal to patient.The piece that the alignment guide attaches to broke off while pounding to the bhr cup in.The procedure was successfully completed without delay and it was unknown how the procedure was completed.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: a bhr curved introducer (part: 90128257, lot: s0703056) was returned for inspection after reporting that the instrument broke during surgery.It was reported that the piece that the alignment guide attaches to broke off while pounding the bhr cup during the procedure.No adverse affects, delays or patient harm was reported.A visual inspection was performed, the product quality was checked and confirmed.Laser markings were slightly faded but fully legible and correct.The product is non functional due to part broken and weakened structure.The part has been seen to be snapped off the device.Damage can be seen showing product misuse in addition to impact damage on the head consistent with surgical use.The threads are acceptable.A review of the complaint history for the bhr curved cup introducer was performed using part & batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the batch.Due to the age of the instrument, and as the manufacturer is out of business, the production records could not be retrieved or reviewed for the instrument reportedly involved in this incident.However, all the released instruments involved would have met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Based on the available information and the returned instrument the probable root cause of this issue are unintentional user error caused by the impactor being hit in the wrong place.If further information is received then the complaint will be reopened and investigated.Based on this investigation, the need for corrective and preventative action is not indicated.The instrument will be retained at aurora uk as it cannot be repaired.

• Brand Name: BHR CURVED CUP INTRODUCER
• Common Device Name: 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
• MDR Report Key: 12103014
• Report Number: 3005975929-2021-00340
• Device Sequence Number: 4816271
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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 Expiration Date: 12/12/2011
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0703056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention