MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 115MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.415S

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: ktt.Occupation: reporter is a j&j representative.The device was received, the investigation is in progress, 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 an unknown date, tfna fenestrated helical blade, ti cannulated tfna nail, and an unknown screw were received broken.There was no procedure and patient involvements are reported.This complaint involves three(3) devices.This report is for (1) tfna fenestrated helical blade 115mm - sterile.This report is 1 of 3 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: updated data: d4, h4.Investigation summary: visual inspection: the tfna fenestrated helical blade 115 -s (p/n: 04.038.415s, lot number: h782248) was received at us cq.Upon visual inspection at cq, it is observed the helical component of the complaint device was deformed.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Device failure/defect identified? yes.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause for the reported condition could be due to unintended force applied to the complaint device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 04.038.415s.Synthes lot # h782248.Supplier lot # n/a.Release to warehouse date: 11 feb 2018.Expiration date: 31 oct 2028.Manufacturing location: elmira.No ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.Corrected data: h3, h6.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 115MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12316133
• MDR Text Key: 266394595
• Report Number: 2939274-2021-04627
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099358
• UDI-Public: (01)10886982099358
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.415S
• Device Catalogue Number: 04.038.415S
• Device Lot Number: H782248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1
• Treatment: 12/130 DEG TI CANN TFNA 440/LEFT-STERILE; UNK - SCREWS: NAIL DISTAL LOCKING