MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 6.5MMX165MM CAN SCR FT SS; SCREW, FIXATION, BONE

Model Number	71106365S
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three of the 6.5mm x 165mm can screws ft stainless steel came sterile packaged with incorrect labeling.These screws are partially threaded but are labeled at fully threaded.There was no case involved.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This issue was previously identified and was evaluated through our internal quality hold process.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is 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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
Corrected data is in the following sections: h6, h7, and h9: the associated device, intended for use in treatment, was not returned for evaluation and the reported event was confirmed.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This issue was previously identified and was evaluated through our internal escalation process.We have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.The health hazard evaluation concluded that in the most likely scenario, the package is opened during surgery and contains a partially threaded version instead of a fully threaded version.The issue is detected prior to use, and a comparable back-up device is used.The procedure is completed with no harm to the patient.In the worst case scenario, the package is opened prior to or during surgery and contains a partially threaded version instead of a fully threaded version.The issue is detected prior to use, and an alternative device(s) is used for the surgery.The health hazard evaluation team recommends escalation to field action board to due to the device appearing to be incorrectly labeled as a fully threaded screw.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this issue was previously identified and was evaluated through our internal escalation process.The package is opened during surgery and contains a partially threaded version instead of a fully threaded version.The issue is detected prior to use, and a comparable back-up device is used.The procedure is completed with no harm to the patient.In the worst case scenario, the package is opened prior to or during surgery and contains a partially threaded version instead of a fully threaded version.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: 6.5MMX165MM CAN SCR FT SS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10781760
• Report Number: 1020279-2020-06094
• Device Sequence Number: 14396167
• Product Code: HWC
• UDI-Device Identifier: 00885556013021
• UDI-Public: 00885556013021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2021

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 Expiration Date: 07/08/2025
• Device Model Number: 71106365S
• Device Catalogue Number: 71106365S
• Device Lot Number: 20GT39417
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 09/28/2021; 12/06/2021; 12/06/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 10/13/2021; 12/06/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0143-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown