MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE; NAIL,FIXATION,BONE

Model Number 04.034.452S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent for a removal surgery.During the surgery, all devices were intact, no items were broken, and were removed successfully and without difficulty.Originally, the patient underwent for removal hardware of a left tibial shaft fracture for infection on (b)(6) 2020.The current removal surgery was completed successfully without any delay.The patient was fin postoperatively.This complaint involves thirteen (13) devices.This report is for (1) 10mm ti cann tibial nail-ex w/prox bend 360mm-sterile.This report is 6 of 13 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4 h6: manufacturing location: monument manufacturing date: october 10, 2019 expiration date: august 31, 2028 part: 04.034.452s, 10mm ti cann tibial nail - ex w/prox bend 360mm ¿ sterile lot: 18p3895 (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.Sterilization control number (scn) supplied by ethicon (abq) was reviewed and determined to be conforming.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 ¿removal due to infection¿ does not indicate breakage of the nail.Therefore, review of the raw materials would not be pertinent to the reported 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.H5.

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12356633
• MDR Text Key: 267822533
• Report Number: 2939274-2021-04822
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982095251
• UDI-Public: (01)10886982095251
• Combination Product (y/n): N
• PMA/PMN Number: K040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 04.034.452S
• Device Catalogue Number: 04.034.452S
• Device Lot Number: 18P3895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/24/2021
• Patient Sequence Number: 1
• Treatment: 2.7MM CORTEX SCREW SELF-TAPPING 20MM; 2.7MM CORTEX SCREW SELF-TAPPING 28MM; 2.7MM CORTEX SCREW SELF-TAPPING 36MM; 2.7MM CORTEX SCREW SELF-TAPPING 38MM; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 44 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 46 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 48 FOR IM NAILS
• Patient Outcome(s): Required Intervention
• Patient Weight: 81