MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE WITH STOPPER 400 MM; PIN, FIXATION, THREADED

Catalog Number	102107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient came into clinic and reported that 2 wires on her frame had snapped.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The devices were fractured and not all pieces were returned.The device batch numbers that were provided could not be verified as valid.The diameter and hardness of the devices were measured and were found to be within specification.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The clinical / medical investigation concluded that insufficient clinical documentation was provided to perform a thorough medical assessment.The patient¿s post external-fixation physical restrictions remain unknown; however, unable to rule out excessive weight bearing or simply complications of an external fixation device in the presence of a chronic non-union post tibial nail infection as possible contributing factors to the reported events.The patient impact beyond the reported broken wires/replacement revisions and the conversion to struts to re-align the tibia cannot be determined.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: WIRE WITH STOPPER 400 MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8582957
• Report Number: 1020279-2019-01781
• Device Sequence Number: 11520601
• Product Code: JDW
• UDI-Device Identifier: 03596010031259
• UDI-Public: 03596010031259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: 102107
• Device Lot Number: 18DT02840
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1