MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRUT MEDIUM; PIN, FIXATION, THREADED

Model Number	71070220
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the five of the strut medium are wearing causing numbers to be unreadable.It is unknown whether the event happened and if there was a patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information ¿b5¿ h3, h6: the device, intended for use in treatment was returned for evaluation: a visual inspection was conducted and confirmed the numbers on the strut medium are wearing causing them to become unreadable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from misuse or rough handling are likely probable causes of the reported event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Event or Problem Description
It was reported that the strut medium is worn causing numbers to be unreadable.It is unknown whether the event happened and if there was a patient involvement.

• Brand Name: STRUT MEDIUM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781305
• Report Number: 1020279-2021-03774
• Device Sequence Number: 861056
• Product Code: JDW
• UDI-Device Identifier: 03596010291028
• UDI-Public: 03596010291028
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Model Number: 71070220
• Device Catalogue Number: 71070220
• Device Lot Number: 17JSM0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1