MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM X 44MM CORT BONE SCR ST SST; PLATE, FIXATION, BONE

Model Number	3571129244
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr, two (2) 4.5mm x 44mm cort bone scr st sst and two (2) 4.5mm x 42mm cort bone scr st sst, were difficult to start insertion of a chs 4 hole 130 deg plate.Surgeon stated that the drill hole had been placed in freehand, therefore was too close to the plate for the screw to bite evenly.The procedure was completed with the same reported screws.However, it is unknown if there was a delayed or not.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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 no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to alignment and procedural/user error or variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: 4.5MM X 44MM CORT BONE SCR ST SST
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12233213
• Report Number: 1020279-2021-06041
• Device Sequence Number: 11737546
• Product Code: HRS
• UDI-Device Identifier: 03596010551887
• UDI-Public: 03596010551887
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K993106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3571129244
• Device Catalogue Number: 3571129244
• Device Lot Number: 19ET22140
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention