MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF INTERFIT DEPTH GAUGE; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number	71362012
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the numbers on the gauge were faded and hard to read, this was discovered while the device was in used.S+n back-up was available and once the incident was noted this device was switched to this one to complete the procedure.No delay or injury reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device does not have numbers on the gage end, just milled notches in the material.The product identification numbers were legible.The measuring end was bent in multiple locations.The device was manufactured in 2008 and shows signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: RF INTERFIT DEPTH GAUGE
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9273782
• Report Number: 1020279-2019-03868
• Device Sequence Number: 16675727
• Product Code: JDH
• UDI-Device Identifier: 03596010198624
• UDI-Public: 03596010198624
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2020

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: 71362012
• Device Catalogue Number: 71362012
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 03/02/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 11/22/2019; 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1