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

Model Number	90127555
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blue rubber of the bhr head impactor is cracking.As this was noticed upon field inspection, no patient was involved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that the blue rubber of a bhr head impactor (part number: 90127555, lot number: unknown) was seen to be cracking.As this was noticed upon field inspection, no patient was involved.The device is for use in treatment.A review of the complaint history for the bhr head impactor was performed using part numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.A review of the complaint history was performed using the part number for the bhr head impactor and the failure mode for the prior 12 months to the aware date.No other similar complaints were identified.Without definitive lot numbers a documentation history review cannot be performed for the instrument involved.However, the released instrument 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.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.It should be noted that the bhr surgical technique (us) 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 devices or further information we cannot further investigate or confirm the reported complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this particular case, our investigation remains inconclusive.Based on the results of this investigation, the need for corrective or preventative action is not indicated.
Additional Manufacturer Narrative
H3, h6.It was reported that the blue rubber of a bhr head impactor (part number: 90127555, lot number: 7071430001) was seen to be cracking.As this was noticed upon field inspection, no patient was involved.The device is for use in treatment.A review of the complaint history for the bhr head impactor was performed using part and lot numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for this instrument.A review of the complaint history was performed using the part number for the bhr head impactor and the failure mode for the prior 12 months to the aware date.No other similar complaints were identified.Due to the age of the instrument, there is no traceability within sap and the manufacturing records for this device cannot be reviewed.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic escalation actions related to the product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.A visual inspection was performed.During the inspection, general wear and tear was observed across the body of the device.Batch and lot numbers were faded but legible.The silicon case was seen to be cracked in two areas.It was visually verified that no metal was shown beneath the overmolding.The 2 small crack lengths in the silicon were measured at 14.11 mm and 9.45 mm respectively (measured with calibrated calipers g0716).It should be noted that the bhr surgical technique (us) 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¿.As the device has been returned, we are able to confirm the reported complaint.Due to the age of the instrument a probable root cause is the device reaching the end of its useful life.We will continue to monitor for failures of these devices, but we have determined that no further action is required at this time.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.

• Brand Name: BHR HEAD IMPACTOR
• 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
• 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: 13295322
• Report Number: 3005975929-2022-00023
• Device Sequence Number: 4835181
• Product Code: NXT
• UDI-Device Identifier: 03596010533272
• UDI-Public: 03596010533272
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90127555
• Device Catalogue Number: 90127555
• Device Lot Number: 7071430001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/28/2022; 06/09/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/01/2022; 06/10/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown