MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.015S

Device Problems Break (1069); Crack (1135)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 the patient underwent revision surgery for one (1) tfna blade and one (1) tfna femoral nail due to pain.After removing the blade, the surgeon noticed the nail was cracked but not completely broken.However, during the removal process the nail completely fractured into two (2) pieces.The implant was initially inserted in (b)(6) 2020.There is no further information available.Concomitant devices reported: unknown tfna end cap (part# unknown, lot# unknown, quantity 1).Locking screw l44 f/nails tan light green (part# 04.005.534, lot# l761200, quantity 1).This report is for one (1) 10mm/125 deg ti cann tfna 235mm/left - sterile.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d11 h3, h6: manufacturing location: monument, manufacturing date: april 17, 2018, expiration date: april 01, 2028, part: 04.037.015s, 10mm/125 deg ti cann tfna 235mm/left ¿ sterile, lot: h612163 (sterile).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 (pll) was reviewed and determined to be conforming.Sterilization control number (scn) supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: part: 04.037.912.2, lock prong 125 degree, tfna, bp55 and lot: l477893.Note: parts originally received as p/n 04.037.942.2 which was incorrect.The parts received were actually 04.037.912.2, 125 degree lock prongs.Labels were reworked to reflect the correct p/n 04.037.912.2.Purchased finished goods traveler met all inspection acceptance criteria.Work order travelers met all inspection acceptance criteria after the rework of the labels.Part: 04.037.912.4, wave spring, shim ended, bp55 and lot: h474714.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)(4) were reviewed and determined to be conforming.Part: 04.037.912.3, tfna lock drive, bp58 and lot: h576521.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 21127, timoagri16.00, bp80 and lot: h435018.Certified test report received from perryman company and certificate of test supplied to perryman by howmet castings were reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.Visual inspection: the investigation of the returned tfna nail has shown that the nail through the proximal tfna blade hole is broken off.On the surface of the parts near the broken area, scratches are visible.Dimensional inspection: the relevant features are heavy damaged in a manner which prevents accurate measurement of the features.The damages are clearly caused post manufacturing.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength, and structural stability.The values were in compliance with ao/asif specification and with the standard specification of astm f2066 for implants for surgery, ti mo15.The fracture face is homogenous, which indicates material conformity.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the complaint is rated as confirmed for this tfna nail as the nail through the proximal tfna blade hole is broken off.Based on the provided information, we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to the reported first crack at the blade hole of tfna nail.Finally broke the tfna nail through the proximal blade hole during the removal procedure as reported.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 as no product related issue could be detected.H11 corrected data: h6 - device codes.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: 10MM/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: 10514038
• MDR Text Key: 206350217
• Report Number: 2939274-2020-04020
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649491
• UDI-Public: (01)07611819649491
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 04.037.015S
• Device Lot Number: H612163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L44 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L44 F/NAILS TAN LIGHT GREEN; TFNA HELICAL BLADE PERF L110 TAN; UNK - END CAPS: TFNA; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; LOCKSCR 5 L44 F/NAILS TAN LIGHT GREEN; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR