MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEPTH GAUGE FOR 1.8MM PEGS/2.4MM SCREWS; PLATE, FIXATION, BONE

Model Number	71158072
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the depth gauge appears was misaligned by 2mm off.Due to this several screws had to be switch out because they were long.No delay was reported.No backup device was needed to finish the surgery because shorter screws were used.
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 was manufactured in 2018 and exhibits signs of moderate wear / usage.The dimensional evaluation found the device to be within specification.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The medical investigation concluded that the complaint reports a ¿depth gauge for 1.8mm pegs/2.4mm screws¿ misaligned by 2mm.Due to this finding several screws had to be switched out for shorter screws.No clinical/medical documentation material was sent for this investigation.The depth gauge was returned for evaluation.The ¿failure mode is not confirmed, as part, functions and measures correctly and as intended.Measurements were taken at the 10, 20, 30mm marks.The impact to the patient was not reported except that the procedure was completed satisfactorily.The probable root cause for the depth discrepancy could have been caused by not locking sleeve on this part.The sleeve must be tightened down securely on to the small sleeve in order for an accurate measurement to be taken per the instructions.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: DEPTH GAUGE FOR 1.8MM PEGS/2.4MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9315208
• Report Number: 1020279-2019-04000
• Device Sequence Number: 390667
• Product Code: HRS
• UDI-Device Identifier: 00885556631720
• UDI-Public: 00885556631720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161665
• 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): 04/15/2020

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: 71158072
• Device Catalogue Number: 71158072
• Device Lot Number: 18GTRS066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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; Required Intervention