MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 3.5MM DEPTH GAUGE SHORT; PLATE, FIXATION, BONE

Model Number	71175069
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our reference number: (b)(4).
Event or Problem Description
It was reported that during surgery, the evos small 3.5mm depth gauge short did measure incorrectly.The procedure continued using a backup device from smith and nephew, without surgical delay and no injury to the patient.
Additional Manufacturer Narrative
H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of extensive use.A dimensional evaluation was done and the returned 3.5mm depth gage short has had the internal ruler (small ruler sub assembly short/ 81094470) swapped out during cleaning in the field with a 2.7mm depth gage short (small ruler sub assembly short/ 81091195).The 3.5mm d.G.Has a 60mm length ruler / the 2.7mm d.G.Has a 50mm length ruler.This ruler swap is the cause of the gages not measuring correctly.Our inspection procedures have measurement callouts to verify these measurements prior to packaging.Rulers were swapped out during cleaning in the field.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.Possible probable cause could include but not limited the user error.At this time, we do not have 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS SMALL 3.5MM DEPTH GAUGE SHORT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11407487
• Report Number: 1020279-2021-01776
• Device Sequence Number: 11904264
• Product Code: HRS
• UDI-Device Identifier: 00885556635872
• UDI-Public: 00885556635872
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 71175069
• Device Catalogue Number: 71175069
• Device Lot Number: 17LTRS0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1