MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4MM TROCAR DRILL SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71631026
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrumentation intra-operatively failed to align proximal femoral implants.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual inspection of the returned devices indicated surface damage and wear from use.These devices were manufactured ranging from four to eleven years ago.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A functional evaluation indicated that we were able to properly duplicate the surgical technique with all the mating components and found no issue with the alignment.All the mating components met the drawing specification and assembled with no issues.Based on the evidence available to us, we are unable to determine a possible issue with the devices; the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: 4MM TROCAR DRILL SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7870810
• Report Number: 1020279-2018-01770
• Device Sequence Number: 13768955
• Product Code: HSB
• UDI-Device Identifier: 03596010604910
• UDI-Public: 03596010604910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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): 12/12/2018

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 Expiration Date: 09/14/2018
• Device Catalogue Number: 71631026
• Device Lot Number: 15DM20769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: Hospitalization