MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 90MM - STERILE; ROD, FIXATION, INTRAMEDULLAR

Model Number	04.038.190S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, the patient underwent revision surgery due to a femoral neck fracture and broken fenestrated tfn advanced screw at fenestration.The broken piece of the fenestrated tfn advanced screw was not removed.The patient was revised to a 130 degree blade plate.There was a surgical delay of forty-five (45) minutes.The procedure was completed successfully.Patient status is stable.Concomitant product: unknown tfna nail (part # unknown, lot # unknown, quantity 1); unknown screws trauma (part # unknown, lot # unknown, quantity 1).This report is for one (1) tfna fenestrated screw 90mm - sterile.This is report 1 of 1 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.A device history record (dhr) review was conducted: part number: 04.038.190s, lot number: h686335, part manufacturing date: 31 july 2018, manufacturing site: elmira, part expiration date: 30 june 2028, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h686335 of tfna fenestrated screws 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 h611883 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.Visual inspection: the x-ray and pictures of the tfna fenestrated screw 90 mm (part # 04.038.190s, lot # h686335, mfg # 31-jul-2018) were received at us cq.The x-ray and pictures showed that tfna screw broke post-operatively within the patient.The broken portion of the device which was left in the patient can be seen.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as the relevant part was not returned.Document/specification review: the relevant drawing(s) was reviewed; a review of the raw material device history record(s) determined the raw material lot h611883 met all specifications with no issues documented that would contribute to this complaint condition.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.
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.Patient age 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
Update: product investigation will be conducted for x-ray and photographs.

• Brand Name: TFNA FENESTRATED SCREW 90MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8473989
• Report Number: 2939274-2019-57221
• Device Sequence Number: 16604171
• Product Code: HSB
• UDI-Device Identifier: 10886982098733
• UDI-Public: (01)10886982098733
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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,Followup
• Report Date (Section B): 03/07/2019

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: 04.038.190S
• Device Catalogue Number: 04.038.190S
• Device Lot Number: H686335
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/23/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/10/2019; 04/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR