MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 90MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.303
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images provided in the attachments "(b)(4) photo, (b)(4) intake email from sales consultant with x-ray photo (b)(6) 2019¿.The images were reviewed, and the complaint condition could be confirmed as the images showed the helical blade penetrating through the frmoral head.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) 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 history lot : part number: 456.303, lot number: 7617875, part manufacturing date: 01 march 2014, manufacturing site: (b)(4), part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 7617875 of ti helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformance's 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 7165083 met all specifications with no issues documented that would contribute to this complaint condition.Device history batch : null.Device history review : a review of the device history record revealed no complaint related anomalies.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.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 hardware removal of titanium trochanteric fixation nail (tfn)  due to helical blade penetrating through femoral head resulting to total hip arthroplasty (tha).Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: tfn - titanium cannulated trochanteric fixation nail (part # 456.328s, lot # h107691, quantity 1), unknown screw (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This is 1 of 1 for report (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.A product investigation was conducted.Visual inspection: the 11.0mm ti helical blade 90mm (p/n: 456.303, lot number: 7617875) was received at us cq.The following investigation is based on the received device and the images provided.The images were reviewed, and the complaint condition could be confirmed as the images showed the helical blade penetrating through the femoral head.Visual inspection of the returned complaint device showed markings of cosmetic damage, but no functional damage was noted.Functional test: a functional test could not be performed since the mating device (tfn) was not returned.The complaint was not able to be replicated.Dimensional inspection: helical blade length, helical blade height and helical blade width before flutes were measured and found to be conforming per relevant drawings.Document/specification review: relevant current and manufactured drawings was reviewed.No design issues or discrepancies were identified.Investigation conclusion: the complaint is confirmed since the attached images show the helical blade penetrating through the femoral head.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) 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: 11.0MM TI HELICAL BLADE 90MM
• 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: 9311743
• Report Number: 2939274-2019-62115
• Device Sequence Number: 2509350
• Product Code: HSB
• UDI-Device Identifier: 10886982226679
• UDI-Public: (01)10886982226679
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 456.303
• Device Catalogue Number: 456.303
• Device Lot Number: 7617875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/ 130DEGTICANNTROCHFIX.NAIL235MM-STERI.; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention