MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 80/75; NAIL, FIXATION, BONE

Catalog Number	71677080
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	04/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery as the screw back-out was confirmed.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: LAG/COMP SCREW KIT 80/75
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6553412
• Report Number: 1020279-2017-00322
• Device Sequence Number: 19119802
• Product Code: JDS
• UDI-Device Identifier: 03596010563286
• UDI-Public: 03596010563286
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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 Expiration Date: 07/19/2026
• Device Catalogue Number: 71677080
• Device Lot Number: 16GT73231
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 09/15/2017
• 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: 77 YR