MAUDE Adverse Event Report: SYNTHES GMBH 7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.017.240S

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Occupation: reporter is a j&j sales representative.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery of osteosynthesis of left humerus, with multiloc nail system.During the surgery, the nail to remain outside about 3mm.There was no fragment generated.The surgery was completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1)7mm ti multiloc humeral nail left/cann/240mm-sterile.This report is 1 of 1 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.Photo investigation: the device was not returned.A photo-investigation was performed on the images located in pc attachment ¿rx1.Jpg" & "rx2.Jpg".Upon inspecting the x-ray images provided, the multiloc humeral nail was observed to be sitting proud of the bone surface by a few millimeters.It was reported that the surgeon did not comply with the surgical procedure, and hence the root cause for the reported issue is determined to be use error.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - part # 04.017.240s, lot # 67p8294, manufacturing site: mezzovico, release to warehouse date: 11-nov-2020, expiry date: 01-nov-2025.A manufacturing record evaluation was performed for finished device lot number, and no non-conformances were identified.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: 7MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12025021
• MDR Text Key: 268304586
• Report Number: 8030965-2021-05067
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819431201
• UDI-Public: (01)07611819431201
• Combination Product (y/n): N
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.017.240S
• Device Lot Number: 67P8294
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/24/2021
• Patient Sequence Number: 1
• Patient Age: 57 YR