MAUDE Adverse Event Report: RAYNHAM SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problems Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.This report is for an unk - nail head elements: tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.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

Device report from synthes reports an event in (b)(6) as follows: it was reported on that (b)(6) 2021, the patient underwent for a surgery.During the surgery, the stepped drill for opening the helical blade generates resistance and burns the bone and blade do not block the nail.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) unk - nail head elements: tfna helical blade.This report is 7 of 7 for (b)(4).Related product complaint: (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): RAYNHAM SYNTHES USA PRODUCTS LLC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12246401
• MDR Text Key: 264133819
• Report Number: 1526439-2021-01563
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 09/27/2021
• Patient Sequence Number: 1
• Treatment: AIM-ARM 130° F/STAT DIST LOCK; BUTTRESS/COMPR-NUT; DRILL BIT F/LATERAL CORTEX OPENING F/DHS; GUIDE SLEEVE YELL; STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH; AIM-ARM 130° F/STAT DIST LOCK; BUTTRESS/COMPR-NUT; DRILL BIT F/LATERAL CORTEX OPENING F/DHS; GUIDE SLEEVE YELL; STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH