MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 105MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.306
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem 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 is report 1 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d10: part returned h3, h6: investigation summary background: (b)(6) 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 11.0mm ti helical blade 105mm was received at us cq.Upon visual inspection at cq, it is observed that the device was received stuck in the tfna in incomplete assembled condition.It is unable to disassemble at cq.The helical blade was stuck with tfna due to a metal piece stuck in tfna hole while placing helical blade.Additionally, the device was observed to have few scratches and discolored spots on the surface.The lot number etched on the device was also illegible due to a scratch on it.The helical tip of the device was deformed.Thus, the reported complaint is 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; -helical blade, trochanteric fixation nail: 456_301 rev.G (current rev) no design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint is confirmed as the helical blade was stuck in tfna.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 lot number of the device was not available.Thus, the dhr cannot be performed.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: 11.0MM TI HELICAL BLADE 105MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9099898
• Report Number: 2939274-2019-60734
• Device Sequence Number: 11405070
• Product Code: HSB
• UDI-Device Identifier: 10886982226730
• UDI-Public: (01)10886982226730
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: 456.306
• Device Catalogue Number: 456.306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: CONNECTING SCREW; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Age: 89 YR