MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMHS CP 130 D 12 X 19.5R; SCREW, FIXATION, BONE

Catalog Number	71683012R
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a nail could not be detached from the target device instruments after implantation.The nail had to be removed and caused a delay of 1 hour.Surgery was continued with a backup device.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual examination indicated that one imhs cp nail, one t-handle, one guide bolt wrench, and one guide bolt were returned with the complaint.Minor scratches are visible on the profile of the proximal and distal holes of the nail.The hex driving feature on the bolt is severely damaged and deformed, potentially preventing proper connection to the wrench in securing the bolt to the nail.All instruments exhibit signs of repeated use and extreme wear.A functional evaluation indicated that the threaded portion of the bolt connects to and detaches from the threaded portion of the nail as intended.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that it was reported that that there was a surgical delay of 1 hour due to a device related incident.It was further reported that there is no harm or adverse injury to the patient as a result of the extended time.Since no patient harm or injury is being reported and the procedure was completed successfully, no further clinical assessment is warranted.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this complaint closed.

• Brand Name: IMHS CP 130 D 12 X 19.5R
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7247832
• Report Number: 1020279-2018-00131
• Device Sequence Number: 997591
• Product Code: HWC
• UDI-Device Identifier: 03596010517845
• UDI-Public: 03596010517845
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2018

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 Catalogue Number: 71683012R
• Device Lot Number: 16GT72683
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 06/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) ; (B)(4)
• Outcome Attributed to Adverse Event: Other