MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT STEM EXTRACTOR UNIV JOINT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71355107
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the redapt stem extractor broke.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that the redapt stem extractor broke.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.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 complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.
Event or Problem Description
It was reported that the redapt stem extractor broke.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.The visual inspection of the returned device also noticed that the tip is bent.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirms a large portion of the bushing broke off.The broken piece was not returned.Also the visual confirms the threaded tip of the device is bent.The device shows significant signs of wear and usage.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints 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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.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.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: REDAPT STEM EXTRACTOR UNIV JOINT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 13545161
• Report Number: 1020279-2022-00749
• Device Sequence Number: 12021721
• Product Code: LZO
• UDI-Device Identifier: 00885556223697
• UDI-Public: 00885556223697
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2022

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: 71355107
• Device Catalogue Number: 71355107
• Device Lot Number: 17APG0055
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 11/15/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/20/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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