MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 3H RIGHT WDE TI 48MM; PLATE, FIXATION, BONE

Model Number	71158403
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right orif distal radius procedure, while surgeon was doing screw insertion (first time for this particular hole), the screw pass through the plate hole, the screw went inside patient¿s bone, it seems the hole on the plate have deformed when he was trying to screw in.The reduction was already done so he managed to turn the screw in a different angle instead of using a different company system.A delay of less than 30 min reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical analysis noted that an undated x-ray was reviewed and confirmed the reported failure.The impact to the patient was the procedure.Since fixation was reported to be achieved no further clinical/medical assessment is warranted.Some potential causes of the reported event could include but are not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation of this report is inconclusive.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.

• Brand Name: EVOS VOLAR PLATE 3H RIGHT WDE TI 48MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551756
• Report Number: 1020279-2020-04653
• Device Sequence Number: 17028737
• Product Code: HRS
• UDI-Device Identifier: 00885556693810
• UDI-Public: 00885556693810
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K181533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 71158403
• Device Catalogue Number: 71158403
• Device Lot Number: 19BT16300S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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
• Patient Age: 41 YR