MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 26CM 125D RIGHT; NAIL, FIXATION, BONE

Catalog Number	71675523
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, the nail for right leg was inserted in the left leg of the patient.Noticed when distal screw could not be implanted correctly.Intervention performed is unspecified.A delay of 30 minutes was reported.Injuries are unspecified.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, this complaint reports that a during procedure, the intertan nail for right leg was inserted in the left leg of the patient.It has been communicated that no clinical documents are available.Per e-mail exchange with quality team in japan the intertan nail chart-stik label confirms that the labeling was correct for the implant.The patients current status has been reported as ¿staying in bed¿.Since this is a procedural error and there is no relevant clinical documentation, no further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 26CM 125D RIGHT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8378687
• Report Number: 1020279-2019-00873
• Device Sequence Number: 1203753
• Product Code: JDS
• UDI-Device Identifier: 00885556344842
• UDI-Public: 00885556344842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 71675523
• Device Lot Number: 18EM02676
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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