MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 INS SPAC TR SZ5-6 15MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71430236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka procedure, a piece of plastic from the insert spacer 5-6 15 mm broke off while trialing the knee.All pieces recovered.A surgical delay no longer than 30 min was reported and a smith and nephew backup was available to complete the procedure.
Additional Manufacturer Narrative
The device used in treatment was returned and evaluated.The spacer trial has signs of wear and tear and it is broken and damaged.According lo clinical/medical investigation, this case reports the a piece of plastic from the insert broke off while trailing.Per email communication, the broken piece was retrieved, and the procedure was completed using a backup device without patient injury, and less than 30-minutes delay.No further clinical assessment is warranted.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch and failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the misuse, heating and cooling associated with autoclaving or prolonged use.A review of risk management files found that the reported failure was documented appropriately.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: G2 INS SPAC TR SZ5-6 15MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814882
• Report Number: 1020279-2020-06336
• Device Sequence Number: 19300756
• Product Code: LXH
• UDI-Device Identifier: 03596010211910
• UDI-Public: 03596010211910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71430236
• Device Catalogue Number: 71430236
• Device Lot Number: 80504651
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 06/16/2021
• 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