MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 95MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.304S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code-hwc.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, there was difficulty getting the helical blade to pass through the nail.The blade was hitting the bottom of the nail.It was as if the nail was a 135 as opposed to 130.The surgeon then tried tightening the nail connection to the insertion handle.The blade guide sleeve connection to the nail insertion handle was also tight.The blade was able to pass manually with the blade guide sleeve and disconnecting the compression nut from the aiming arm.The nail was locked distally through the loving sleeves and finished the case.The original blade was removed and tried implanted a second set of helical blade.Procedure was successfully completed with a ten (10) minute surgical delay.Patient outcome was good.Concomitant devices reported: unknown insertion handle (part#unknown, lot#unknown, quantity 1), unknown guide sleeve (part#unknown, lot#unknown, quantity 1), unknown aiming arm (part#unknown, lot#unknown, quantity 1), unknown compression nut (part#unknown, lot#unknown, quantity 1) this report is for one (1) 11.0mm ti helical blade 95mm-sterile.This is report 2 of 2 for (b)(4).
Additional 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.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant date is not 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.
Additional 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, h4, h6: a device history record (dhr) review was conducted: part number: 456.304s lot number: 9938661 part manufacturing date: 08 december 2015 manufacturing site: elmira part expiration date: 31 october 2024 nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies.The device history record shows lot 9938661 of ti helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 9825561 met all specifications with no issues documented that 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.

• Brand Name: 11.0MM TI HELICAL BLADE 95MM-STERILE
• 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: 8531351
• Report Number: 2939274-2019-57568
• Device Sequence Number: 1474654
• Product Code: HSB
• UDI-Device Identifier: 10886982226709
• UDI-Public: (01)10886982226709
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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 Expiration Date: 10/31/2024
• Device Model Number: 456.304S
• Device Catalogue Number: 456.304S
• Device Lot Number: 9938661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 05/17/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/15/2019; 05/22/2019
• Patient Sequence Number: 1
• Patient Age: 81 YR