MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM X 24MM CTX SCR S-T; SCREW, FIXATION, BONE

Model Number	72403524
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the evos 3.5mm x 44mm lck scr s-t package was labeled as a 44 mm but the actual measure is 34 mm, the evos 3.5mm x 42mm lck scr s-t package was labeled as a 42 mm but the actual measure is 28 mm and the evos 3.5mm x 24mm ctx scr s-t package was labeled as a 24 mm but the actual measure is 30 mm.The action taken was to re-measured screws before handing to surgeon before insertion, so surgeon removed the above screws and drilled again due to adjustment with plates.Screws were measured differently to above, hence used different length evos screws.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that the evos 3.5mm x 44mm lck scr s t package was labeled as a 44 mm but the actual measure is 34 mm, the evos 3.5mm x 42mm lck scr s t package was labeled as a 42 mm but the actual measure is 28 mm and the evos 3.5mm x 24mm ctx scr s t package was labeled as a 24 mm but the actual measure is 30 mm.The action taken was to re measure screws before handing to surgeon before insertion.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed at this time.Our investigation by our quality team indicated that vision machines are utilized for all lots before packaging to verify the length of the parts.After reviewing the documentation of the reported lot, it can be concluded that all parts are conforming at the time of distribution from a documentation standpoint.Complaints search was performed and found no other records of non-conformance with involved lot.All vision report included in the device historical records indicates parts are conforming.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.No patient harm has been reported, therefore, no further clinical/medical; assessment is warranted at this time.Based on this investigation and with no product available for evaluation, no root cause can be determined at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Event or Problem Description
It was reported that the evos 3.5mm x 44mm lck scr s-t ((b)(4); mhra: 2020/008/025/401/003) package was labeled as a 44 mm but the actual measure is 34 mm, the evos 3.5mm x 42mm lck scr s-t ((b)(4); mhra: 2020/010/008/701/046) package was labeled as a 42 mm but the actual measure is 28 mm and the evos 3.5mm x 24mm ctx scr s-t ((b)(4); mhra: 2020/010/008/701/050) package was labeled as a 24 mm but the actual measure is 30 mm.The action taken was to re-measured screws before handing to surgeon before insertion, so surgeon removed the above screws and drilled again due to adjustment with plates.Screws were measured differently to above, hence used different length evos screws.Screws were discarded and are not available for evaluation.

• Brand Name: EVOS 3.5MM X 24MM CTX SCR S-T
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10675609
• Report Number: 1020279-2020-05365
• Device Sequence Number: 2991475
• Product Code: HWC
• UDI-Device Identifier: 00885556634370
• UDI-Public: 00885556634370
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72403524
• Device Catalogue Number: 72403524
• Device Lot Number: 20AM14983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 72413542, EVOS 3.5MM X 42MM LCK SCR, LOT:19AM02717; 72413544, EVOS 3.5MM X 44MM LCK SCR, LOT:19MB00183
• Outcome Attributed to Adverse Event: Required Intervention