MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.(b)(4).Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.Device history lot.Part number: 456.305.Lot number: h745097.Part manufacture date: oct 03, 2018.Manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0mm ti helical blade 100mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material 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.Device history review.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal of a titanium cannulated trochanteric fixation nail due to non-union.The titanium cannulated trochanteric fixation nail was removed with no issues and a total hip arthroplasty was performed.The procedure was successfully completed with no surgical delay.There was no patient consequence.This complaint involves 3 devices.This is report 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
This is report 2 of 4 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 100MM
• 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: 10093145
• Report Number: 2939274-2020-02536
• Device Sequence Number: 777203
• Product Code: HSB
• UDI-Device Identifier: 10886982226716
• UDI-Public: (01)10886982226716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 456.305
• Device Catalogue Number: 456.305
• Device Lot Number: H745097
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.0MM TI HELICAL BLADE 100MM; 11MM/130 DEG TI CANN TRH FXTN NAL 400MM/RT; 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS; 11.0MM TI HELICAL BLADE 100MM; 11MM/130 DEG TI CANN TRH FXTN NAL 400MM/RT; 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR