MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT/TC/TC P.S. REV. PIN EXTRACTOR

Model Number	75005420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up of a juk procedure, the pin extractor screw came off and was noticed broken.The device was not used.The procedure was completed without a second device and with no delays.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during set up, the pin extractor screw came off.Device was not used.The device, used in treatment, was returned for evaluation.It can be confirmed that on of the pins of the device has fallen out and is missing.A dimensional evaluation of the remaining device, did not show any deviations.The pin itself could not be measured, since it was not returned.The relationship between the reported event and the device can be confirmed.The production documentation did not show any deviations from standard manufacturing processes.Since this device is visually checked before release for distribution, it can be stated, that the pin was in place at release.Retrospectively it cannot be assessed whether the pin was fully seated as required.This is the first complaint which was received for this device.The risk is covered through the risk management file.A review is attached.Review of past corrective actions was performed.No further escalation is required.The root cause for the disassembly of the device stays undetermined after investigation.Without the pin, it is not possible to speculate about contributing factors.Actions were implemented to check the position and holding force of the pin.To date, the need for further actions is not indicated.Smith and nephew will monitor this event for further similar issues.Internal complaint reference: (b)(4).

• Brand Name: RT/TC/TC P.S. REV. PIN EXTRACTOR
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13546343
• Report Number: 9613369-2022-00035
• Device Sequence Number: 17439944
• Product Code: HWB
• UDI-Device Identifier: 07611996052732
• UDI-Public: 07611996052732
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/21/2022

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: 75005420
• Device Catalogue Number: 75005420
• Device Lot Number: D67802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/21/2022
• 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