MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.195S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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.Device history lot: part number: 04.038.195s, lot number: h732466, part manufacturing date: 27 september 2018, manufacturing site: (b)(4), part expiration date: (b)(6) 2028, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h732466 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 h653777 met all specifications with no issues documented that would contribute to this complaint condition.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 the patient underwent a removal surgery of a short trochanteric femoral nailing system advanced (tfna) nail due to a lateral protrusion of the lag screw on an unknown date.Originally, the patient was originally implanted in (b)(6) 2019.The patient was suffering of length discrepancy from collapsed.The tfna was removed and exchanged for a total joint.Tfna nail, lag screw, and distal locking screw removed without incident.Procedure and patient outcome are unknown.Concomitant devices reported: tfna nail (part# 04.037.112s, lot# h759956, quantity# 1).Distal locking screw (part# 04.005.526s, lot# h772128, quantity# 1).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 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: 9268154
• Report Number: 2939274-2019-61906
• Device Sequence Number: 1850229
• Product Code: HSB
• UDI-Device Identifier: 10886982098757
• UDI-Public: (01)10886982098757
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 04.038.195S
• Device Catalogue Number: 04.038.195S
• Device Lot Number: H732466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR