MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 110MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.307S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code hwc.It is unknown if device will be returned.Reporter is company representative; no facility contact available.No code available is for surgical/medical intervention.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 an unknown date during a trochanteric femoral nail (tfn), a 125 degree nail was implanted in the patient but the doctor did not have a 125 degree helical blade aiming arm so a 130 degree arm was used instead.The helical blade was left upside down in the patient and nail.The nail could not be locked.It is unknown if there was surgical delay.Patient and procedure outcome are unknown.This is report 3 of 3 for (b)(4).(b)(4) captures the intra operative tfn event, for the aiming arm and nail that could not be locked while (b)(4) captures the post op event where the tfn was revised due to failed locking mechanism.
Additional Manufacturer Narrative
Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.A review of the device history record: device history lot: this lot was manufactured by (b)(4).On 08 july 2019 by (b)(4): part number: 456.307, lot number: 6615828, part manufacturing date: 07 march 2011, 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 6615828 of ti helical blades was processed through the normal manufacturing and inspection operations with no rework or non conformances 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 6506050 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.Part # & explant date provided for reporting.Manufacturing site provided for reporting.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
On (b)(6) 2019: it was reported that the device was put in improperly and it could not be locked because the helical blade was upside down.

• Brand Name: 11.0MM TI HELICAL BLADE 110MM
• 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: 8744061
• Report Number: 2939274-2019-58908
• Device Sequence Number: 1680082
• Product Code: HSB
• UDI-Device Identifier: 10886982226761
• UDI-Public: (01)10886982226761
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/03/2019

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: 456.307S
• Device Catalogue Number: 456.307
• Device Lot Number: 6615828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention