MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CAN ACET SCREW 35MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71336535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a hip necrosis procedure, when placing the device, the screw broke from the upper part (head) at the time of turning it, so the screw goes through the r3 cup.According to the sales representative it is not certain if the problem is the screw or if the hole in the cup is bigger than it should be.No additional damage was reported.The procedure was successfully completed without delay using the same device.The patient condition was reported as stable.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, the screw broke from the head during insertion.Reportedly, the procedure was successfully completed without delay using the same device and the patient condition was reported as stable.However, responses to the clinical requests have not been received as of the date of this medical investigation.S+n has not received supporting documentation to fully evaluate the root cause of the reported events.The patient impact beyond the reported screw breakage could not be determined; however, the patient condition was reportedly stable.Since the procedure was reportedly completed with the same implantable component, material characteristics and biocompatibility is not a concern.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents 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.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, surgical technique, user error or 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: UNIV CAN ACET SCREW 35MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12085457
• Report Number: 1020279-2021-05527
• Device Sequence Number: 3502912
• Product Code: JDI
• UDI-Device Identifier: 03596010197689
• UDI-Public: 03596010197689
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K920430
• 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): 08/19/2021

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: 71336535
• Device Catalogue Number: 71336535
• Device Lot Number: 20HM11063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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: Other; Required Intervention