MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 INS SPAC TR SZ3-4 13MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	74033634
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a univ insert spacer size 3-4 13m was cracked.No case involved.
Additional Manufacturer Narrative
Internal complaint reference number: case-(b)(4).Section b5, d1/d2 and d4 were updated with the new information received.
Event or Problem Description
It was reported that a g2 ins spac tr sz3-4 13mm was cracked.No case involved.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has multiple gouges and scratches on the mating surfaces preventing the device from performing as designed.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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 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: G2 INS SPAC TR SZ3-4 13MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11853505
• Report Number: 1020279-2021-04490
• Device Sequence Number: 3502422
• Product Code: LXH
• UDI-Device Identifier: 03596010672063
• UDI-Public: 03596010672063
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74033634
• Device Catalogue Number: 71430226
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 07/15/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/23/2021; 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1