MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.5MM HEX HOLDING SLEEVE 2CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71175099
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 2.5mm hex linear driver shaft case (b)(4) and a 2.5mm hex holding sleeve case (b)(4) were not capturing.It is unknown whether this problem was noticed in a surgical environment or not.Therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
Additional corrected information was received for this event.Reference to sections: d1, d4, g3, h2.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device shows signs of extensive use.A functional evaluation of the returned device confirmed the stated failure mode.The ball bearings of the mating ball bearing in question was worn and loose.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 2.5MM HEX HOLDING SLEEVE 2CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12042966
• Report Number: 1020279-2021-05332
• Device Sequence Number: 14364424
• Product Code: LXH
• UDI-Device Identifier: 00885556651346
• UDI-Public: 00885556651346
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/13/2021

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: 71175099
• Device Catalogue Number: 71176002
• Device Lot Number: 19LCT0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 10/12/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/05/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1