MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIN REDUCTION FORCEPS W/PTS - BROAD

Catalog Number	71175084
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection of the returned device confirms the forceps are bent.The device exhibits signs of significant wear/usage.The manufacture date is 2018 for this device.Dhr and complaint history review not performed for this event, as no manufacturing, packaging or labeling defects were associated with the reported failure.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Credit will be issued for this device.
Event or Problem Description
It was reported that during procedure the tip of forceps are bending.No injuries or delays reported.Backup device available.No more information provided yet.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection of the returned device confirms the forceps are bent.The device exhibits signs of significant wear/usage.The manufacture date is 2018 for this device.Dhr and complaint history review not performed for this event, as no manufacturing, packaging or labeling defects were associated with the reported failure.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: SPIN REDUCTION FORCEPS W/PTS - BROAD
• Common Device Name: FORCEPS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8942551
• Report Number: 1020279-2019-03223
• Device Sequence Number: 11516024
• Product Code: HTD
• UDI-Device Identifier: 00885556636671
• UDI-Public: 00885556636671
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/02/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71175084
• Device Lot Number: 18FTCD037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1