MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE BOLT WRENCH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631140
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during set up or inspection, a guide bolt wrench was not sent.The missing item was not communicated to the hospital or the representative by customer services and this was not picked up until the patient was on the table.The procedure was completed using a s+n back-up device.Surgery was delayed for more than 30 minutes (approximately 1 hour).Patient was under anesthesia.
Additional Manufacturer Narrative
Based on the documentation provided of the trigen base instrument set, it can be confirmed that the checkbox was not marked for the guide bolt wrench, therefore the instrument was missing in order to be used during the surgery.The clinical/medical investigation concluded that, based on the information provided, while this patient was under anesthesia, the sales rep.Had to travel to another facility for a replacement instrument due to a missing guide bolt wrench for the trigen base tray, delaying surgery approximately one hour.According to the report, once the replacement instrument was given to the surgeon, the procedure was completed without complications.Therefore, since no harm has been alleged to this patient due to the extended surgical delay, no further clinical/medical assessment is warranted at this time.A review of complaint history for the previous 12 months did not reveal similar complaints for this type of event.A review of the risk management file revealed that the failure mode of product availability with the associated harm of delay in the surgery has been previously identified.This failure mode could be caused by a planning error.The anticipated risk level is still adequate.A historical review concluded that there are no prior escalated actions related to this part number nor related to the reported event.At this time, based on the information provided, there is no allegation that the product failed to meet any product specifications at the time of manufacture.The cause for this event was most likely an internal planning error.The contribution of the device to the reported event could be corroborated, as there was a delay in surgery and a need for a back up device.As the device was missing, it was not available for evaluation.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: GUIDE BOLT WRENCH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12878024
• Report Number: 1020279-2021-08423
• Device Sequence Number: 4434237
• Product Code: HSB
• UDI-Device Identifier: 03596010419644
• UDI-Public: 03596010419644
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 71631140
• Device Catalogue Number: 71631140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown