MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/RT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.008.028S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, the surgeon struggled to seat the titanium hindfoot arthrodesis cannulated nail on to insertion handle.The nail was eventually attached but required some force.The event occurred intra-op but prior to incision.The additional force was applied to fully seat the implant on the insertion handle.The case was not delayed in any way.The procedure successfully completed.There was no patient consequence.This report involves 1) 10mm ti hindfoot arthrodesis cann nail-ex 240mm/rt-sterile.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: august 29, 2021.Expiration date: july 31, 2030.Part number: 04.008.028s, 10mm ti hindfoot arthrodesis cann nail ¿ ex 240mm/rt-sterile.Lot number: 272p143 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿struggled to seat nail onto insertion handle¿ does not indicate breakage of the nail.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/RT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12896040
• Report Number: 2939274-2021-06860
• Device Sequence Number: 19820335
• Product Code: HSB
• UDI-Device Identifier: 10886982087188
• UDI-Public: 10886982087188
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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 Model Number: 04.008.028S
• Device Catalogue Number: 04.008.028S
• Device Lot Number: 272P143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSRT H&LE F/HINDFOOT ARTHRO NAIL-EX
• Patient Sex: Unknown