MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.037.115S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

It was reported that during an intramedullary (im) nailing of intertrochanteric fracture on (b)(6) 2020, the trochanteric fixation nail advanced (tfna) fenestrated screw got stuck in the tfna nail and could not be advanced or pulled back.The nail was able to be removed and exchanged with another nail.A second tfna set was used to proceed with the case.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.Concomitant device reported: tfna screw inserter (part # 03.037.025 lot # l503499, quantity 1), connecting screw for tfna helical blade and screw (part # 03.037.026 lot # l987541, quantity 1), extraction instrument for tfna helical blade and screw (part # 03.037.030, lot # 534061, quantity 1); tfna fenestrated screw 85mm (part # 04.038.185, lot # unknown, quantity 1).This report is for one (1) 11mm/125 deg ti cann tfna 235mm/left, sterile.This is report 2 of 2 for (b)(4).

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.H3, h6: manufacturing location: monument, manufacturing date: 31-mar-2020, expiration date: 28-feb-2030, part number: 04.037.115s, 11mm/125 deg ti cann tfna 235mm/left- sterile, lot number: 49p4912 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17567 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿fenestrated screw got stuck in the nail and could not be advanced or pulled back¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 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: 11MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10621596
• MDR Text Key: 209636658
• Report Number: 2939274-2020-04468
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096333
• UDI-Public: (01)10886982096333
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.115S
• Device Catalogue Number: 04.037.115S
• Device Lot Number: 49P4912
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Patient Sequence Number: 1
• Treatment: HELICAL BLADE/SCREW COUPLING SCREW.; HELICAL BLADE/SCREW EXTRACTOR.; SCREW INSERTER.; TFNA FENESTRATED SCREW 85MM.; HELICAL BLADE/SCREW COUPLING SCREW; HELICAL BLADE/SCREW EXTRACTOR; SCREW INSERTER; TFNA FENESTRATED SCREW 85MM