MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. 3MM X 25MM SST HALF PIN; PIN, FIXATION, THREADED

Catalog Number	71063251
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a malfunction in which surgeon was performing a rt tkr using brainlab, implants were implanted and whilst removing the 3.0mm brainlab tibial pin it snapped at the threaded junction.The surgeon was able to successfully remove the pin and no harm to the patient was caused.Minor delay was reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.Credit cannot be issued for this device.

• Brand Name: 3MM X 25MM SST HALF PIN
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7912639
• Report Number: 1020279-2018-01933
• Device Sequence Number: 2063884
• Product Code: JDW
• UDI-Device Identifier: 03596010487063
• UDI-Public: 03596010487063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K944143
• 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): 11/22/2018

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 Catalogue Number: 71063251
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1