MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED

Catalog Number 357.371

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

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 (b)(6) 2019, the patient underwent a trochanteric femoral nail procedure, the locking mechanism that rotationally locks the helical blade or lag screw fell down into the nail during the operation before it was supposed to.The following are the devices used during the insertion of the helical blade: unknown helical blade insertion handle, unknown connecting screw, aiming arm, outer sleeve through the aiming arm.While inserting the helical blade, the blade got stuck halfway between fully inserted and coming out, and unable to extract the helical blade or advance it forward because it¿s a little too in the locking mechanism broke off and got ledge in between the helical blade and the nail itself in the middle.There was a backup device used, the nail and helical blade were removed and a new nail and blade were used.There was a difficulty in the removal.The doctor attempted to use standard tfn extraction instrumentation but was unsuccessful as the helical blade was not able to be removed independently from the nail.Eventually, he extracted both the nail and blade out together.The following are the devices used in the case but are unable to disassemble them: aiming arm, blade guide sleeve and buttress/compression nut.They did not cause any patient harm and were not returned to use.There were no fragments generated from the broken device.There was a surgical delay of thirty minutes.The procedure was completed by taking out the nail with the helical blade still stuck halfway through the eyelet in the nail then another nail was implanted.Patient status is stable.This is report 5 of 5 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: investigation summary background: 09/20/2019: modified event description:it was reported that on (b)(6) 2019, the patient underwent a trochanteric femoral nail procedure, the locking mechanism that rotationally locks the helical blade or lag screw fell down into the nail during the operation before it was supposed to.The following are the devices used during the insertion of the helical blade: unknown helical blade insertion handle, unknown connecting screw, aiming arm, outer sleeve through the aiming arm.While inserting the helical blade, the blade got stuck halfway between fully inserted and coming out, and unable to extract the helical blade or advance it forward because it¿s a little too in the locking mechanism broke off and got ledge in between the helical blade and the nail itself in the middle.There was a backup device used, the nail and helical blade were removed and a new nail and blade were used.There was a difficulty in the removal.The doctor attempted to use standard tfn extraction instrumentation but was unsuccessful as the helical blade was not able to be removed independently from the nail.Eventually, he extracted both the nail and blade out together.The following are the devices used in the case but are unable to disassemble them: aiming arm, blade guide sleeve and buttress/compression nut.They did not cause any patient harm and were not returned to use.There were no fragments generated from the broken device.There was a surgical delay of thirty minutes.The procedure was completed by taking out the nail with the helical blade still stuck halfway through the eyelet in the nail then another nail was implanted.Patient status is stable.Concomitant device reported: unknown insertion instrument (part# unknown, lot# unknown, quantity# unknown), unknown connecting screw (part# unknown, lot# unknown, quantity# unknown).This complaint involves five (5) devices.Investigation flow: device interaction visual inspection: the buttress/compression nut for 357.369 was received at us cq.Upon visual inspection at cq, it is observed that the device shows normal wear without any physical damage consistent with the usage of the device.But it is observed that the compression nut is screwed in with guide sleeve and got stuck on it.Thus, the complaint can be confirmed.Functional inspection: functional inspection cannot be performed at cq, as the device was received in stuck condition.Documentation/ specification review: the following drawing(s) was reviewed; -buttress/ compression nut for blade guide sleeve, tfn: 357_371 rev.B, rev.C and rev.D.No design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, and document specification review of the received device was performed at cq.The complaint can be confirmed as the device was found to be stuck on the guide sleeve.The lot number of the complaint device could not be determined as it is not etched on the device and provided.Thus, review of the manufacturing record evaluation could not be completed.A definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 review the lot number of the complaint device could not be determined as it is not etched on the device and provided.Thus, review of the manufacturing record evaluation could not be completed.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: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9100697
• MDR Text Key: 195564197
• Report Number: 2939274-2019-60744
• Device Sequence Number: 1
• Product Code: HST
• 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: 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: CONNECTING SCREW; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Age: 89 YR