MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLIERS,COMPACTION,10MM (REF P/N 13502); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7209446
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl procedure.During the insertion of the bone block from the graft into the femoral tunnel that the bone block split longitudinally.Graft had to removed fully from the knee so the piece of bone could be excised, graft then passed through both tunnels with ease.Tunnels were prepared and smoothed appropriately and no impingement at the tunnels were observed.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.

• Brand Name: PLIERS,COMPACTION,10MM (REF P/N 13502)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7174323
• Report Number: 1219602-2018-00045
• Device Sequence Number: 1951612
• Product Code: LXH
• UDI-Device Identifier: 03596010468581
• UDI-Public: (01)03596010468581(10)L29211
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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 Model Number: 7209446
• Device Catalogue Number: 7209446
• Device Lot Number: L29211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR