MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.7MM S-T CRTX LCK SCR 10MM; PLATE, FIXATION, BONE

Model Number	71802310
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation procedure, it was found that a 2.7mm s-t cortex lck scr 10mm and the screw driver could not be connected after opening the sterile package.The procedure was finished without delay using a smith and nephew back up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is missing the hex feature in the head, rendering it inoperable.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.A dimensional inspection also found the device is missing its hex feature and is therefore out of specification.This issue was evaluated through our internal nonconformance process and determined to be isolated at this time.The implemented controls and detection points are adequate to capture this type of defect and is not considered a systemic issue.The potential probable cause for this event is a manufacturing process error.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.

• Brand Name: 2.7MM S-T CRTX LCK SCR 10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12125648
• Report Number: 1020279-2021-05766
• Device Sequence Number: 14346942
• Product Code: HRS
• UDI-Device Identifier: 03596010573902
• UDI-Public: 03596010573902
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 71802310
• Device Catalogue Number: 71802310
• Device Lot Number: 19KM13279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1