MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHS LAG SC 105M 4.13; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	121110
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lag screw is damaged.Lag screw damaged the plate as well.A delay of 40 min for the back up to arrive was reported.No injury reported.A back up device was available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.

• Brand Name: CHS LAG SC 105M 4.13
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8364364
• Report Number: 1020279-2019-00757
• Device Sequence Number: 1924074
• Product Code: HSB
• UDI-Device Identifier: 03596010061850
• UDI-Public: 03596010061850
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K933027
• 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
• Report Date (Section B): 07/06/2019

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: 121110
• Device Lot Number: 17AT80786
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 07/06/2019
• 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