MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.5MM PROVISIONAL FIXATION PIN - 40MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71175095
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgeon attempted to place 2.5 x 40mm provisional fixation pin into the distal hole of an evos proximal tibia plate.After drilling the provisional fixation pin halfway across the diaphysis the pin snapped just below the ball of the pin.Surgeon extracted the broken pin with vise grips.All pieces could not be retrieved from patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and during the procedure while drilling the 2.5 x 40mmprovisional fixation pin into the distal hole of an evos proximal tibia plate the pin snapped just below the ball of the pin.The surgeon extracted the broken pin with vise grips and placed a permanent screw in its place.It was communicated that no harm or injury came to the patient during the delay, the surgeon was ultimately satisfied with the outcome and does not anticipate any future medical interventions.Since no harm to the patient is being reported no further medical assessment is warranted.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.

• Brand Name: 2.5MM PROVISIONAL FIXATION PIN - 40MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8592017
• Report Number: 1020279-2019-01815
• Device Sequence Number: 11262171
• Product Code: LXH
• UDI-Device Identifier: 00885556635933
• UDI-Public: 00885556635933
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 71175095
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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: Hospitalization; Required Intervention