MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLASSIC CHS PL 3 SLOT 135 DEG; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	124126
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the lagscrew insiter was damaged.So it damaged the lagscrew and plate as well.A backup device was available and more than 30 minutes of delay was reported.
Additional Manufacturer Narrative
Pma/510k correct date added.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing or product specifications for the batch did not reveal abnormalities that could have contributed to the reported issue.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.No further actions are being taken at this time.

• Brand Name: CLASSIC CHS PL 3 SLOT 135 DEG
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8394921
• Report Number: 1020279-2019-00914
• Device Sequence Number: 3026278
• Product Code: KTT
• UDI-Device Identifier: 03596010072863
• UDI-Public: 03596010072863
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K993289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2019

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 Catalogue Number: 124126
• Device Lot Number: 17JT93000
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019; 03/01/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/06/2019; 11/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR