MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE NUT; APPARATUS, TRACTION, NON-POWERED

Model Number 394.42

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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) 2020, patient underwent an open reduction internal fixation (orif) of right tibial plateau.During the procedure the nut on the femoral distractor got stuck in the middle of the bar.It got cross threaded either when it was being put into position or when it was being taken off.During the procedure they were not able to disconnect it; even using pliers.After the procedure, the bolt was able to be removed with some struggle.It was noted when the device had been assembled before the procedure, it was a little stiff, but it went together nicely.The procedure was successfully completed with no delay reported.This report is for a spindle nut.This is report 2 of 2 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.H3, h6: a product investigation was completed: the device was received with the internal threads stripped.No other issues were identified with the returned components of the device.Dimensional inspection could not be conducted due to post manufacturing damage.The drawing, reflecting the manufactured and current revision, were reviewed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.The complaint condition is confirmed as the internal threads were stripped.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: SPINDLE NUT
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10817952
• MDR Text Key: 215572769
• Report Number: 2939274-2020-05070
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982199706
• UDI-Public: (01)10886982199706
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 394.42
• Device Catalogue Number: 394.42
• Device Lot Number: 4L61264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 14.0MM THREADED SPINDLE 480MM; 14.0MM THREADED SPINDLE 480MM