MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AP CUTTING BLOCK SZ 7; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	E0016926-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pin on the back of cutting block appeared to be bent, when surgeon tried to push it straight, it broke off.
Additional Manufacturer Narrative
A visual inspection of the returned cutting block confirms the stated failure.One of the spikes on the device broke off.The spike was returned with the device for evaluation.The device was manufactured in 2020.The device exhibits signs of normal wear and use.A medical investigation and per complaint details, the bent-appearing pin on the back of cutting block ¿broke off¿ when the surgeon ¿tried to push it straight¿.Reportedly, the instrument ¿was never near patient or used¿ and ¿standard blocks (were) used for surgery without issue¿.Although the patient was under anesthesia, it was communicated that there was no surgical delay or resultant harm to the patient.The product evaluation confirmed the breakage and the fractured portion was returned with the instrument.Since no patient involvement other than a backup instrument used for the procedure, no further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file for the product was conducted.Factors and/or some potential probable causes that could include but not limited to inadequate design for strength of spikes.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no 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 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.

• Brand Name: AP CUTTING BLOCK SZ 7
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10583386
• Report Number: 1020279-2020-04843
• Device Sequence Number: 3161224
• Product Code: LXH
• UDI-Device Identifier: 00885556779873
• UDI-Public: 885556779873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: E0016926-1
• Device Lot Number: 20CM15742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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