MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE RT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71360090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a thr surgery during smacking the dbl offset broach hdle rt, the mechanism that captures the head of the broach became broken.Surgery was finished with a s&n back up device, without any surgical delay.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.A functional evaluation of the returned device could not confirm the stated failure mode.The device functioned as intended; however, the mating broach was slightly loose within the broach handle.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of 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.Assessment of historical escalated cases concluded that there are no prior actions related to this product and failure mode.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: DBL OFFSET BROACH HDLE RT
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 12782170
• Report Number: 1020279-2021-07940
• Device Sequence Number: 5749610
• Product Code: JDG
• UDI-Device Identifier: 03596010610362
• UDI-Public: 03596010610362
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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 Model Number: 71360090
• Device Catalogue Number: 71360090
• Device Lot Number: 14CM07089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown