MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.5MM PROVISIONAL FIXATION PIN - 25MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71175094
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery a pf pin was inserted into the hard cortical bone, at that moment the plate positioning wasn't right, so the pin was removed and adjusted.It was advised the product is single-use, but the same pin was driven into a new position higher up the hard cortical tibia bone, upon attempting to remove the pin it snapped and left 25mm of steel in the leg.No delay in the procedure.

• Brand Name: 2.5MM PROVISIONAL FIXATION PIN - 25MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9615503
• Report Number: 1020279-2020-00360
• Device Sequence Number: 11366931
• Product Code: LXH
• UDI-Device Identifier: 00885556635926
• UDI-Public: 00885556635926
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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 Model Number: 71175094
• Device Catalogue Number: 71175094
• Device Lot Number: 17HNX0016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 12/28/2020
• 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
• Patient Age: 25 YR