MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS BROACH SIZE 1; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71363501
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that during use inside the patient, the surgeon was unable to connect the trial neck.This was due to the size 1 and the size 3 broaches having a step down laterally to accommodate the trial neck.Because this step down sits below the neck cut it prevents the trial neck from being inserted.We managed to trial eventually but with one size, either took a lot of effort to get the neck in and with the other size sitting the broach high and then sinking with the neck attached.Surgical delay less than 30 minutes.The procedure finished with the same device.Patient injuries were not reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that after broaching, the surgeon was unable to connect the trial neck, due to the broach having a step down laterally to accommodate the trial neck.The sales rep indicated that when engaging the broach with the trial neck there was difficulty, as the broach itself has a step down on the superolateral portion which sits underneath the femoral neck cut.Therefore, it was very difficult to get the trial neck on, and the surgeon had to partially remove the broach and re-impact the broach and neck as one construct in order to trial.Per complaint detail, there was no patient injury, and the procedure was completed using the same device with a minimal delay.With no patient harm alleged, no further clinical assessment is warranted.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CPCS BROACH SIZE 1
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11099513
• Report Number: 1020279-2020-08083
• Device Sequence Number: 11793897
• Product Code: JDG
• UDI-Device Identifier: 03596010467119
• UDI-Public: 03596010467119
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71363501
• Device Catalogue Number: 71363501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 09/01/2021
• 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