MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.242S

Device Problem Crack (1135)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown date in 2019.Device history review: part number: 04.037.242s, 12mm/130 deg ti cann tfna 170mm - sterile, lot number: h804500 (sterile), manufacturing location: (b)(4), manufacturing date: 09-jan-2019, expiration date: 30-nov-2028, lot quantity: (b)(4).Work 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 was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 15870 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: part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h613142, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from (b)(6) dated 07-sep-2018 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna, bp55, lot number: 2l25923, lot quantity: (b)(4), work order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h799604, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h783300, lot quantity: (b)(4).Certificate of analysis supplied by metalwerks inc.Dated 07-nov-2018 was reviewed and determined to be conforming.Lot summary report dated 13-nov-2018 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.(b)(4).Investigation summary: the cannulated trochanteric femoral nail was received at the us cq.The outer coating had been scraped, consistent with implantation and explantation.The walls of the opening for the fenestration screw both had cracks running from one end to the other laterally.On the side with the inner lock, the crack went fully through between both ends.The inner surface of this side, there were a number of grooves carved in.The inner lock itself was broken off at the base of its shaft.The fragment was not returned.The other side of the nail¿s crack did not fully extend from one opening to the other and did not got all the way through from the surface to the inside.The section of the shaft above the crack was slightly bent outward from its midline.No other issues could be identified with the returned portions of the device.Dimensional inspection: proximal end outer diameter: 15.66+/-0.1mm, measured dimensions: proximal end outer diameter above cracks: 15.66mm, conforming, proximal end outer diameter below cracks: 15.66mm, conforming, device(s) used: ca802.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) no issues.The received device (part # 04.037.242s lot # h804500) was manufactured at the (b)(4) site on 09 january 2019.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The complaint was confirmed for the cannulated trochanteric femoral nail.The walls of the opening for the fenestrated screw on the nail had cracks running through them.The inner lock had broken, and the fragment was not returned.There were scratches on the outside and inside of the device.The scratches on the inside ran parallel to the crack on the inner lock¿s side of the nail.The device had bent slightly about the crack that did not fully cut through the nail.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.No definitive root cause could be determined, but it is possible that the device had encountered unintended forces.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 Description

It was reported the patient underwent revision surgery due to hip and femur pain on an unknown date.Originally, the patient was implanted with the trochanteric femoral nailing system advanced (tfna) on (b)(6) 2019.X-rays were taken on an unknown date and the nail appeared bent or crooked.During the removal, a crack was seen in the surgical x-rays.Upon inspection of the removed nail, it was obvious that it was cracked but not completely broken.A new tfna construct was implanted.The surgery was completed with no harm to the patient.This is report 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 Description

Further it was reported that the patient underwent revision surgery due to hip and femur pain on (b)(6) 2019.

• Brand Name: 12MM/130 DEG TI CANN TFNA 170MM - 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: 8836695
• MDR Text Key: 152506052
• Report Number: 2939274-2019-59420
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097262
• UDI-Public: (01)10886982097262
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.242S
• Device Catalogue Number: 04.037.242S
• Device Lot Number: H804500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 08/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75